INFORMATION ON SYMTOMS OF AIDS HIV TREATMENT FOR HIV AIDS TESTS FOR HIV AIDS VACCINE DRUGS RESEARCH

Anti retroviral drugs of class protease inhibitors drugs and increased blood cholesterol level.

noreply@blogger.com (Martin) — Mon, 05 Sep 2011 18:28:00 +0000

Antiretroviral drugs belonging to class protease inhibitors are known to cause increase in cholesterol level in patients taking protease inhibitors drugs. Anti retroviral protease inhibitors drugs which act by inhibiting enzyme protease , this enzyme helps HIV virus in building its protein by breaking higher proteins in to smaller on, and then make use of these smaller one for building HIV and viral envelop and thus help in reproduction of HIV virus.

Every drug do not specifically act on a particular system, but they do have some varied degree of action on other metabolic and biochemical systems and cycles, antiretroviral drug belonging to category protease inhibitors cause increase in cholesterol, in a broader term this class of drug may cause hypertriglyceridemia, hypercholesterolemia and the increased cholesterol level in patients and subject them to high risk of developing atherosclerosis, by increasing the level atherogenic lipoproteins and endothelial dysfunction which increase the risk of atherosclerosis and heart disease.

Drug Norvir, is known to cause more hyperlipidemia compared to other protease inhibitor drugs . Also a non protease drug Sustiva is also known to increase blood lipid levels. Other underlying factors like smoking , alcohol consumption , and low physical activity , which affect lipid metabolism and are responsible for increased blood cholesterol level must be considered , there is great risk of developing hyperlipidemia with those underlying factors.Patient are advised to quite smoking and do some physical exercise regularly, must avoid alcohol.

What is done when a patient develop hyperlipidemia :
Hyperlipidemia associated with protease inhibitors is a reversible type which means it ceases if changes are made in antiretroviral drugs to treat hyperlipidemia, doctor decide up on consideration of the risk of hyperlipidemia compared to viral count and patients health, hyperlipidemia is also managed with exercise and altering the food to low fat diet.

Incase of sever conditions following drugs which lower blood cholesterol are given
Statins : Lipitor (atorvastatin) and Pravachol (pravastatin).
Fibrates: Lopid (gemfibrozil) and Tricor (fenofibrate)

All above drugs have serious side effects in high dose and long term , for example, drug belonging to group statins are known to cause rhabdomyolysis and drug belonging to group Fibrates are known to increase risk of developing gall stone.

Source:

http://www.jci.org/articles/view/16261#B5

http://www.aidsinfo.nih.gov/contentfiles/Hyperlipidemia_FS_en.pdf

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Authored by : B V Waghmare

Last updated: 06-Sep-2011

HIV vaccine research, B Cells can be stimulated with proteins on HIV virus region which do not change and produce antibodies which can neutralize HIV virus.

noreply@blogger.com (Martin) — Tue, 30 Aug 2011 19:07:00 +0000

National institute of health led researchers found route to guide B cells to produce antibodies against HIV which can neutralize HIV the research provides a clue for development of HIV vaccine. .

Days are not far when researchers will be successful in developing a vaccine for HIV, so far there is no vaccine available against HIV, in last few years HIV vaccine research has seen many setbacks and failures, researchers too have learned from those failures, we too strongly believe that a vaccine for HIV is just not a dream but it is a possibility. HIV vaccine will be of great importance when combined with other drugs. A hope comes from the fact that there lies a region on HIV which do not show much variation which is known as cd4 binding site, developing proteins similar to those regions which can be used to evoke B cells for production of antibodies against HIV which can neutralize HIV virus and thus can be used as vaccine against HIV.

The process of developing a vaccine for HIV is not less than solving a puzzle, where it is required to unwind lot of facts about the process and mechanism with which HIV infect and replicate in human body, the enzyme systems and the genetic constitution of each and every HIV strains, and finding how HIV antigens are recognized by human immune system, how genes code for proteins which can neutralize HIV virus, and how to present these proteins to human immune system so that it can stimulate the production of antibodies against incoming HIV virus which they can neutralize by binding with it, so that, those proteins can be used as vaccine.

Scientists at Vaccine Research Center (VRC) and the National Institute of Allergy and Infectious Diseases (NIAID) which is a part of National Institutes of Health, are successful in finding the facts about how some HIV neutralizing antibodies are developed in human body, they have found the map or route with which human B cells can develop a immune response which can trigger production of antibodies against HIV virus which can successfully neutralize HIV virus by binding with it.

One of the interesting fact about this discovery is that variation in genetic material of HIV occurs due to greater degree of mutation in HIV in all strains, which is a biggest hurdle in developing an effective vaccine against HIV, which makes virus to change its genes which are then difficult to recognize by human body in event of encounter with HIV virus. A hope comes from the fact that there lies a region on HIV which do not show much variation which is known as cd4 binding site.

Last year VRC scientists discovered three antibodies of which two antibodies can stop HIV from infecting humans by neutralizing HIV virus, these antibodies can stop almost ninety percent of known HIV strains from infecting humans.

These antibodies were named as VRC01, VRC02 and VRC03 , these antibodies against HIV were found in blood sample of North American named as donor 45 , further in a new study researchers found antibodies similar to VRC01 in the blood donated by two Africans which were already infected with HIV they were called as donor 74 and donor 0219.

Scientists found that the genes which code for VRC01 protein are present over DNA in B cells, which are responsible for imparting immunity our body. These gens are responsible for coding VRC01 like proteins which can neutralize HIV virus.

Scientists studied the gens responsible for coding VRC01 by method known as deep sequencing, this method is used first time in HIV vaccine research to find the path way of evolution of the antibody response to HIV virus to genetic level. Scanning of B-cell DNA libraries of donor 45 and donor 74 was done, and the genes which code for HIV neutralizing antibodies were grouped at one place.

Further researchers studied the gene segment which coded for the part of VRC01-like antibody which binds to HIV virus and neutralize. Study of sequence in new found relative genes which code VRC01 discovered how step by step changes in the sequence turned it to into a mature form. A vaccine which evoke VRC01-like antibodies is required to coax the B-cell DNA of immature antibodies to evolve along one of these pathways.

Researchers are now focused on developing proteins which will guide B Cells step by step , guide them towards develop a immune response for formation of antibodies against HIV which can neutralize HIV virus in the same manner as that of VRC01 antibodies.

Source: http://www.niaid.nih.gov/news/newsreleases/2011/Pages/HIVAntibodyEvolution.aspx

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Last updated:30-Aug-2011

Authored by: B V Waghmare.

Testing for HIV infection

noreply@blogger.com (Martin) — Sat, 09 Jul 2011 12:27:00 +0000

Tests for HIV are used to detect the presence of HIV infection in ones body, the tests can detect the HIV in blood , urine and saliva , the main principle behind these tests are detection of HIV antibodies, antigen or RNA of HIV. And the tests employed for detection are

1. ELISA

2. Western Blot

3.Polymerase Chain Reaction.

4.Rapid point of care test kits

A. Home Access Express HIV-1 Test
B. OraQuick this test can be applied on saliva or oral swabs.
C. Orasure
D. Uni-Gold
E. Clearview Complete HIV 1/2 and Clearview HIV 1/2 Stat-Pak
F. INSTI™ HIV-1 Antibody Test is the latest test available to which gives result in 60 seconds.
G. Reveal HIV

If ELISA or other point of care test is positive the test result must be confirmed with Western Blot, ELISA test alone can not be used for confirmation of positive result. PCR test involves direct detection of HIV RNA which is considered highly accurate.

When a test result for HIV is false negative? (actually HIV positive but tests show negative results)

Result of the HIV test may be negative or false negative immediately after encountering the HIV infection as seroconversion do not occur immediately it may take about 30 days to develop antibodies against HIV, in certain cases it may take longer time therefore if the person has not taken any medication should be tested immediately after 30 days, if he is tested positive a confirmatory test must be done, even if the patient is tested negative the test should be conducted again after a period of 30 days, if there is a history of risk of getting HIV infection in the patient they should be given pre exposure prophylactic drugs for HIV until further confirmatory test are done.

If a person has taking post exposure prophylactic medications for HIV, then the test may not give positive result even after 30 days, therefore the person should be advised to do test again after period of 30 days for about seven to eight months without discontinuing the medications.

Information about Various tests for HIV

The ARCHITECT HIV Ag/Ab Combo Assay: This HIV test is capable of identifying HIV infection in early stage as it detects both HIV 1 antigen p24 and antibodies hence helps in early detection of HIV infection

There are many tests kits available in market which are used as rapid HIV testing kits, which are used as the point of care tests kits, they are used in hospitals and other places where it is required to find out if a person is HIV positive or not, not only blood sample but the saliva and urine can be used with these test kits for knowing if a person is HIV positive or not, all positive results obtained with the rapid test kit tests must be confirmed with Western Blot. One must take up the regular tests like ELISA followed by Western Blot or PCR for confirmation of HIV testing results.

HIV infection and AIDS is on of the disease which has affected millions of homes world wide , and if we do not work today to prevent HIV it will be a biggest enemy of mankind.
There is only one effective way to protect every on from getting HIV infection is to educate every one about how HIV is spread from one individual to other and how it is not transmitted.
The most important aspect of HIV prevention is getting HIV test done, it is very difficult to convince people to get HIV testing done, they should be encouraged to take up HIV testing if they are more susceptible for getting HIV infection.
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Source:
Lists of tests for HIV screening

HIV Testing/resources/qa

OraQuick Rapid Tests for HIV

FDA approved rapid antibody tests for HIV

PCR test for HIV nucleic acid detection
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Refer following pages for detailed information on HIV virus and Its prevention and AIDS symptoms HIV symptoms and research

Information on HIV virus,

HIV virus morphology / structure of HIV virus ,

Replication of HIV virus ,

Multiplication of HIV virus

What is AIDS?

When does AIDS occurs?

HIV symptoms

Early symptoms of HIV infection ,

AIDS symptoms

Treatment for HIV infection.

Treatment for AIDS

Which are currently available drugs to treat HIV infection?

What is HAART? What is HAART regimen for HIV

Why HAART regimen of drugs given? Why HAART?

Which food a HIV positive should eat ?

Which things a HIV positive should avoid ?

Why there is no vaccine for AIDS and HIV?

Why drugs are not effective against HIV?

Who discovered HIV virus?

How HIV virus is transmitted from mother to her child?

Drug development against HIV virus , Drug Resistance assays and analysis during drug development

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New nonnucleoside reverse transcriptase inhibitors for treating patients who never recived any anti retroviral drug before

noreply@blogger.com (Martin) — Tue, 31 May 2011 18:08:00 +0000

New drug is now available for HIV positive patients who have never taken any treatment.

There is a new drug development in the treatment of HIV positive individual, now a new drug is approved by US food and drugs administration , the new drug is a non nucleoside reverse transcriptase inhibitor, which can be used to lower the higher HIV 1 viral load in blood of HIV positive individuals which never received any anti retroviral treatment before, as the task is a challenging one the newly available drug will be able to provide better tratement option in such cases along with HAART.

Brand name of this drug is Edurant which contains rilpivirine, Raritan, N.J-based Tibotec Therapeutics, a division of Centocor Ortho Biotech Inc has developed this drug.

Rilpivirine

The drug molecule rilpivirine is a diarylpyrimidine derivative which resembles the pyrymidine nucleotides in complementroy DNA and tymine nucleotide in RNA in HIV virus which, owing to its similarity to the chemical resemblance to pryamidine nucleotides, It act by inhibiting HIV virus replication, by blocking enzyme reverse transcriptase. Rilpivirine drug molecule also exhibit some level of conformational isomerism which make this drug molecule to bind with pryrimidine nucleosides strongly preventing them from replication, making this drug molecule active even in higher HIV viral load conditions.

Nucleotide reverse transcriptase inhibitor drugs have therapeutic index to a lower side (moderate) compared to non nucleoside reverse transcriptase inhibitors, that means they nonnucleoside reverse transcriptase inhibitors posses less toxic side effects than nucleotide reverse transcriptase inhibitor drugs , although there is greater likely hood of developing drug resistance in case of nonnucleocide reverse transcriptase inhibitors, the drug should not be discontinued once it is started and a desired low viral level is maintained throughout. There are also some drug resistance assays available with which one can predict the likely hood of drug resistance with a particular antiretroviral drug.

Edurant rilpivirine is approved by US food and drugs administration as a drug to be used in a highly active antiretroviral therapy (HAART) regimen which is targeted to reduce the HIV virus load in the infected individual . The dose of the drug is once a day pill taken with food.

The drug can be used in patients who had not received any prior HIV therapy as the drug Edurant (rilpivirine) in a clinical trail effectively reduced the initial higher HIV viral load in the blood of infected individuals to a level of HIV virus undetectable level is blood.

Side effects include (insomnia) difficulty sleeping, headache,depression, and rash.
The drug Edurant(rilpivirine) do not cure HIV or AIDS ( no drug in the world cure HIV AIDS rather they help in improving quality of life and extending life) therefore US FDA has advised patients to stay on with continuous with their therapy for HIV and related diseases. and other AIDS symptoms

Source:
http://aac.asm.org/cgi/content/full/48/10/3684?view=long&pmid=15388420

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm256087.htm

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Links for more information over treatment for HIV positive and AIDS symptoms , new drug research and development on HIV vaccine research, latest updates.

Information on HIV virus,

HIV virus morphology / structure of HIV virus ,

Replication of HIV virus ,

Multiplication of HIV virus

What is AIDS?

When does AIDS occurs?

HIV symptoms

Early symptoms of HIV infection ,

AIDS symptoms

Treatment for HIV infection.

Treatment for AIDS

Which are currently available drugs to treat HIV infection?

What is HAART? What is HAART regimen for HIV

Why HAART regimen of drugs given? Why HAART?

Which food a HIV positive should eat ?

Which things a HIV positive should avoid ?

Why there is no vaccine for AIDS and HIV?

Why drugs are not effective against HIV?

Who discovered HIV virus?

How HIV virus is transmitted from mother to her child?

Drug development against HIV virus , Drug Resistance assays and analysis during drug development

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Tests for detection of HIV infection

noreply@blogger.com (Martin) — Mon, 30 May 2011 08:42:00 +0000

Test for HIV. Information on HIV testing
Main principle of detection of HIV infection is presence of antibodies against HIV virus in the HIV virus infceted individual, more reliable tests identify presence of HIV genetic material or RNA for detection of presence of HIV virus infection.

ELISA test detect the presence of antibodies against HIV virus in ones blood, if ELISA test comes out to be positive then a confirmatory test which is known as Western blot is done to confirm the result.
Lastly a test called as polymerase chain reaction PCR is used finally to confirm the presence of HIV virus in once body, as immediately after infection human body don't develop antibodies against the virus, which is also known as latency period, hence alternatively presence of HIV virus in blood can be detected by using polymerase chain reaction, in this test if there is presence of HIV, in blood, the RNA of HIV is picked up by the test and precisely detected, this test is one of most reliable test.
There are other rapid test kits available in market which provides solution to provide test at the point of care in medical emergencies, these tests too are required to be confirmed later with other confirmatory tests for HIV.
Following are some of the rapid tests currently available for detection of HIV infection.
1. Home Access Express HIV-1 Test
2. OraQuick this test can be applied on saliva or oral swabs.
3. Orasure
4. Uni-Gold
5. Clearview Complete HIV 1/2 and Clearview HIV 1/2 Stat-Pak
6. INSTI™ HIV-1 Antibody Test is the latest test available to which gives result in 60 seconds.
7. Reveal HIV
Above test are based on detection of antibodies these test should be confirmed with tests which make use of PSR like Quantiplex bDNA and , branched DNA test , as in latency period person might be tested negative .
CD4 count is not the test for presence of HIV virus , cd4 count may go down in certain viral and bacterial disease or because of certain drugs.

Knowing status of HIV infection as early as possible helps in starting medication, early medications can provide better quality of life.

This post will be updated later and we will try to provide complete technical details about HIV testing.

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Source:
Lists of tests for HIV screening

HIV Testing/resources/qa

OraQuick Rapid Tests for HIV

FDA approved rapid antibody tests for HIV

PCR test for HIV nucleic acid detection
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Last updated : 30-May-2011

Dr. A H Bandivdekar finds the inhibitor for sexual transmission of HIV virus.

noreply@blogger.com (Martin) — Sun, 29 May 2011 21:42:00 +0000

Dr. A H Bandivdekar finds the inhibitor for sexual transmission of HIV virus.
Dr. A H Bandivdekar Indian scientist found the exact way by which HIV virus gains entry in to human blood in sexual transmission of HIV virus, which is one of the biggest reason for HIV virus infections and AIDS.
We have few great out comes about process HIV virus infection. Amongst them Dr. A H Bandivdekar’s findings about mannose receptor involvement in sexually transmission of HIV virus will be of great value as it is going to save life’s of millions of peoples.

• Some individuals are tested HIV positive for years and do not develop AIDS.

1. There are certain individuals who are tested positive and do not develop symptoms of AIDS or AIDS this is because there is diffrerance in their genetic constitution , which do not allow HIV virus to grow in them so that they do not develop AIDS. Dr. Bruce Walker etal.

2. Just after HIV infection a person do not develop AIDS immediately . In latancy period there is a resistance for replication of HIV virus in lymphocytes in these infected individuals. There are certain CD 8 cells in HIV positive individuals which resist replication of HIV virus by not supporting synthesis of reverse transcriptase enzyme. Identifying these cells and using fractions of these cells could increase the latancy period in HIV positive individuals. Kannagi M etal.

• Work of Dr. A H Bandivdekar :- Finding mannose receptor responsible for transmission of HIV virus through vaginal lining in to blood.

CD4 independent binding of HIV gp120 to mannose receptor on human spermatozoa
Dr. A H Bandivdekar from India , Department of Biochemistry, National Institute for Research in Reproductive Health, Indian Council of Medical Research, Parel, Mumbai, observed that there are certain couples where even after tested HIV positive the HIV virus is not transmitted to the partner ,
Systematic study and thinking by Dr. A H Bandivdekar led him to finding the key difference in the peoples who transmit the disease and who do not.
So far it was known to world that CD4 receptors were responsible for attachment and carrying HIV virus in to blood for further reproduction by replication.
Careful investigation by Dr. A H Bandivdekar proved that there is absence of CD4 receptors in viginal linings , and led to establish the possibility of different receptor responsible for transmission was studied and it was proved that there are different receptors than CD4 now known as mannose receptor are responsible for transmission of HIV trough vaginal lining , and in females which did not got HIV infection even after male partner being HIV positive it was found that these females lacked mannose receptors.
To establish this HIV gp120 protein which is an important part of HIV virus HIV gp120 protein has great role in the process of HIV virus infection was studied for its (HIV gp120 protein) binding to mannose receptors in human spermatozoa by Dr. A H Bandivdekar .
Dr. A H Bandivdekar has now found a molecule which can prevent transmission of HIV virus through these receptor, it will provide life saving remedy for peoples who are at high risk of getting HIV virus infection through sexual transmission.
Dr. A H Bandivdekar’s findings are really appreciable and encouraging the research on HIV and AIDS.

Referances
http://www.ncbi.nlm.nih.gov/pubmed/18614929

http://news.harvard.edu/gazette/story/2010/05/new-insights-into-the-mystery-of-natural-hiv-immunity/

http://gateway.nlm.nih.gov/MeetingAbstracts/ma?f=102196055.html

B V Waghmare (2011). Dr. A H Bandivdekar finds the inhibitor for sexual transmission of HIV virus.
http://bvwaghmare.blogspot.com/ : bvwaghmare

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Last updated: 29-May-2011

Call For The World...For This World.

noreply@blogger.com (Martin) — Sun, 28 Nov 2010 14:01:00 +0000

Call for world AIDS Day!

HIV/AIDS is one of the major issues in front of every nation today , if we do not find ways to fight against HIV it has capability to affect every family in world. HIV virus do not recognise any boundaries of any nation , it do not understand difference of languages , neither it understand differences between poor and rich , women or child or men.

Neither we have drugs or vaccines which are so effective against HIV , which are so effective so that they can completely make a person free from HIV virus, never the less a timely diagnosis and treatment with anti retroviral medicines without any interruption can help an individual to live a quality life for almost time span equivalent to ones life span.

The real meaning of cure from HIV and AIDS for this world lies in the education about this disease.

We need to educate every individual about how HIV spreads from one individual to other.
One can then will be able to take precautionary measures to protect him self or herself from getting HIV infection.

"In order to educate peoples we should discuss this issue regularly, and preventive measures to be taken to prevent getting HIV infection in our regular discussions too, discuss amongst friends and in offices , there should be a session dedicated to HIV AIDS awareness in each office , in each school in each college .
Discuss as we discus movies , that will spread awareness.

Discuss as we discus about wars.
War against spread of HIV virus.

And army of each one of us ....then we will be successful in preventing the spread of HIV virus."

It is very easy to adapt simple precautions than providing treatment later .
Find over this blog i have posted about precautionary measures to be taken to prevent HIV virus transmission.

Its very easy to protect some one from getting HIV virus infection by adapting simple precautions than researching a drug or vaccine.

Following is my message every one in this world
Join me ! fight against HIV virus and AIDS !

I am pharmacist and a pharmaceutical , drug research and development analyst and a scientific writer .
I am writing over my blog to encourage ongoing research and development all around the glob over anti retroviral drugs and vaccines , and to encourage our scientists working over antiretroviral drugs and Vaccines.

I like to write on my blog about how important a human life is.

We get our life once, and we should live it in full throttle, as we get it , we should equally enjoy the happiness and pain in it, as we get all these once in life.

I write about motherhood of a women , so how important women's are for this world .

If you like and appreciate my efforts if you really feel that i deserve a place in heart of you all , then please say something about me over your blog or website by writing a testimonial about my blog, providing a link to my blog http://bvwaghmare.blogspot.com/ from your website or blog it will ease our pain in reaching the every individual in this world and tel every one out there and educate them about precautions to be taken for avoiding this disease.

Its World AIDS day on 1 Dec 2010.

Can we demonstrate to this world that a effort taken by an individual like us too are important to eradicate HIV from this world.

Please forward this message to all of your friends kiths and kins family members and colleagues in your office, so that it reaches out to millions of peoples before 1 Dec 2010.

To E mail This Article To your Friend Follow This Link .

( I will appreciate a NGO or Government website of any nation if they refers this blog from theirs.)

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Last updated: 28-Nov-2010

HIV vaccine research heading towards success,so near but so far, latest research and development towards developing HIV vaccine

noreply@blogger.com (Martin) — Wed, 24 Nov 2010 16:06:00 +0000

HIV vaccine research heading towards success,so near but so far, latest research and development towards developing HIV vaccine

Our readers ask us many questions like, why there is no vaccine so far available against HIV virus? we are trying to answer question may be I feel there could be the solution in the problem it self, its our great belief that there could be a vaccine developed against HIV virus.
Question: Is it true that some peoples get infected and do not develop any symptoms and live their normal life without developing disease AIDS?

Answer: Yes there are few cases observed where some people are tested HIV positive long ago but have not developed AIDS symptoms or the AIDS disease in their entire life and are called by researchers for finding out what is the key difference in them and the other peoples which is imparting capability for not developing HIV infection in to disease AIDS in such individuals.
Researchers have observed that there is a key difference in the genetic constitution of such peoples and they are termed as controller of the HIV virus.

Further researchers after testing such 974 controllers and about 2500 patients they have found that there is a difference in the protein that triggers on our bodies immune system response in event of an incoming infection. The protein responsible for triggering or alerting immune system has about five amino acids different than that of in others.

This is latest finding in anti retroviral drug and vaccine research and is one of the great finding.
We can isolate and synthesize this protein and study it further and we can use it in developing a new peptide drugs * which could help in imparting similar immunity triggering response in peoples susceptible to HIV virus infection , This will lead to developing antibodies against the HIV virus and inhibiting HIV virus further from invading our bodies T-lymphocytes.

Or this protein can be used along with present antiretroviral drugs, to reduce the resistance of HIV virus towards presently available anti retroviral drugs in HAART regimen

( Also see novel approach towards drugs against HIV virus , developing a peptide called "MIX" )

Getting rid of HIV virus before it invades in to T-lymphocytes is a key factor in success of a HIV vaccines.

An antigens (Vaccines) so for developed as vaccines were able to produce the antibodies against the HIV virus but they could not stop the HIV virus multiplication and replication of HIV virus already invaded in to T-Lymphocytes, that is why we are not able to produce a vaccine which can impart life long immunity to every one against incoming infection of HIV virus.

Latest research towards developing HIV vaccines are more focused to develop vaccines that act precisely against the protein parts in HIV virus which impart HIV virus its ability to invade T lymphocytic cells and integrate its genetic material in to it, like gp 120 and gp 41 proteins , the pattern of their special orientation while invading and attaching the human cell is one of the important factor which protect HIV virus against our bodies immune system in initial stages of infection.
(*We have mentioned in our earlier article about how a proteins too can be used as an anti viral activity these proteins can be designed to form a chain along side the complementary DNA during replication and inhibit replication)

Source:
http://news.harvard.edu/gazette/story/2010/05/new-insights-into-the-mystery-of-natural-hiv-immunity/

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Here are some links to articles which provide complete information on HIV virus and Its prevention and AIDS symptoms , HIV symptoms and research

Information on HIV virus,

HIV virus morphology / structure of HIV virus ,

Replication of HIV virus ,

Multiplication of HIV virus

What is AIDS?

When does AIDS occurs?

HIV symptoms

Early symptoms of HIV infection ,

AIDS symptoms

Treatment for HIV infection.

Treatment for AIDS

Which are currently available drugs to treat HIV infection?

What is HAART? What is HAART regimen for HIV

Why HAART regimen of drugs given? Why HAART?

Which food a HIV positive should eat ?

Which things a HIV positive should avoid ?

Why there is no vaccine for AIDS and HIV?

Why drugs are not effective against HIV?

Who discovered HIV virus?

How HIV virus is transmitted from mother to her child?

Drug development against HIV virus , Drug Resistance assays and analysis during drug development

Latest development on treatment for HIV and AIDS

Latest Research on HIV vaccine

Stem Cell treatment For HIV infection a research article

Novel approach towards developing anti retro viral drug , a peptide that is able to kill HIV virus

Genetically engineered stem cells in treatment of HIV

Netralising antibodies against HIV virus

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HEPA filter

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B V Waghmare (2010). Information on HIV virus and antiretroviral drugs and antiAIDS vaccine research and developmets
www.bvwaghmare.blogspot.com : DOI/arXiv/bvwaghmare

Last updated: 24-Nov-2010

Information about HIV virus AIDS symptoms HIV symptoms treatment for HIV positive

noreply@blogger.com (Martin) — Mon, 15 Nov 2010 11:41:00 +0000

Here is the complete list of articles over this blog which will provide you in depth information about HIV virus
HIV virus life cycle , HIV infection early symptoms and symptoms of AIDS.

What is AIDS? How AIDS disease is developed and why there is no treatment available for AIDS.
All such questions that arise in minds of a layman and a researchers working world wide are answered here over this blog.

You will find lot of information about HIV over this blog only as author of this website is associated with research and development organisation which are working on developments of antiretroviral drugs and vaccines.

There is so far no cure for AIDS but one can live a normal life if he is detected early and starts medication on time without missing drug dose any time.

There is no cure but there is are very simple methods to avoid getting this disease.
Adapt simple preventive measures, and save this world from spread of HIV virus.
AIDS is a disease that is a biggest crisis in front of this world but still everyone of us have closed our eyes and letting this disease spread with its full capability.

Take initiative and decide that you will adapt your self and teach others including your family members and friends about precautionary measures to stop spreading HIV virus.
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Also See Bibilography here
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Information on HIV virus,

HIV virus morphology / structure of HIV virus ,

Replication of HIV virus ,

Multiplication of HIV virus

What is AIDS?

When does AIDS occurs?

HIV symptoms

Early symptoms of HIV infection ,

AIDS symptoms

Treatment for HIV infection.

Treatment for AIDS

Which are currently available?

What is HAART? What is HAART regimen for HIV

Why HAART regimen of drugs given? Why HAART?

Which food a HIV positive should eat ?

Which things a HIV positive should avoid ?

Why there is no vaccine for AIDS and HIV?

Why drugs are not effective against HIV?

Who discovered HIV virus?

How HIV virus is transmitted from mother to her child?

Drug development against HIV virus , Drug Resistance assays and analysis during drug development

Latest development on treatment for HIV and AIDS

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Last updated: 15-Nov-2010

Who discovered HIV virus and tests for diagnosis of HIV infection?

noreply@blogger.com (Martin) — Mon, 15 Nov 2010 11:28:00 +0000

Who discovered HIV virus and tests for diagnosis of HIV infection?

HIV virus AIDS history. In 1981 AIDS disease was first identified, as a disease that is life threatening.

Montagnier and Dr Gallo discovered virus that causes AIDS as HIVvirus.
In 1983 HIV virus was first grown by Dr Gallo and Montagnier in vitro , in a laboratory
In 1985 the first commercial test to detect HIV virus was developed.
Montangnier was awarded Noble prize for his contribution in the discovery.

Dr Robert C. Gallo. Who worked for National Institutes of Health's National Cancer Institute, USA, till 1996 as head of Laboratory of Tumor Cell Biology, he is now a director of The Institute of Human Virology. University of Maryland School of Medicine, Baltimore

Dr Robert C. Gallo who had discovered retroviruses HTLV -1 and HTLV-11 virus that causes cancers , initially it was said that HTLV virus was responsible for AIDS later it was demonstrated by Dr Gallo that (Human immune deficiency virus) HIV virus is responsible for AIDS , this discovery was very important point in developing the test for diagnosis for HIV infection, diagnosis test was also been developed by Dr Robert C. Gallo.

In 1976 Dr Robert C. Gallo and his colleagues discovered Interleukin-2, a growth regulating substance which is now is used in treatment of certain therapy in some cancer.

Dr Gallo is a great human being who has served for well being of mankind, decided to become a researcher in medicine after he lost his 8 year old sister to cancer when he was a young boy.

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Mother to child HIV virus transmission

If a mother is HIV positive then there are high chances that her baby too gets HIV virus infection, most often HIV infection is passed on from mother to child during delivery, when baby comes in contact with mother’s blood, other route for infection is breast feeding. HIV virus also get transmitted from mother to her child through breast milk .Hence following precautions should be taken.
1.HARAT regimen of drug during pregnancy to reduce HIV virus load.
2.Avoiding breast feeding .(Its an critical issue as mothers milk too is essential) some alternate infant feed formulas should be tried , or other nursing mothers milk should be provided to infant.)
3.New born infants too are given antiretroviral drug treatments.

Source:

"The Nobel Prize in Physiology or Medicine 2008". Nobelprize.org. 6 Aug 2011
http://nobelprize.org/nobel_prizes/medicine/laureates/2008

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1881839/pdf/bmj00073-0071.pdf

http://news.bbc.co.uk/2/hi/health/7654214.stm

http://www.pasteur.fr/ip/easysite/pasteur/en/press/press-kits/hiv-aids-research-at-the-institut-pasteur/the-discovery-of-the-aids-virus-in-1983

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Information on HIV virus,

HIV virus morphology / structure of HIV virus ,

Replication of HIV virus ,

Multiplication of HIV virus

What is AIDS?

When does AIDS occurs?

HIV symptoms

Early symptoms of HIV infection ,

AIDS symptoms

Treatment for HIV infection.

Treatment for AIDS

Which are currently available?

What is HAART? What is HAART regimen for HIV

Why HAART regimen of drugs given? Why HAART?

Which food a HIV positive should eat ?

Which things a HIV positive should avoid ?

Why there is no vaccine for AIDS and HIV?

Why drugs are not effective against HIV?

Who discovered HIV virus?

How HIV virus is transmitted from mother to her child?

Drug development against HIV virus , Drug Resistance assays and analysis during drug development

Latest development on treatment for HIV and AIDS

Last updated:6-Aug-2011

Why there is no vaccine for AIDS and HIV , Why drugs are not effective againgst HIV

noreply@blogger.com (Martin) — Mon, 15 Nov 2010 11:19:00 +0000

Why drugs available against HIV are not effective to the level which can save life?
Why there is no vaccines against AIDS is developed yet?

HIV virus multiplies with a great speed, and that is one of the reason that , there occurs lot of changes in genetic material of HIV virus that is a change in gene occurs which is called as mutation , after a mutation , the virus in which mutation takes place gives rise to a different virus that has very different genetic combination .
This is one of reason that HIV virus develops Drug Resistance against a particular drug .
That means a drug which was active against the HIV virus is not so active now against newly aroused HIV virus after mutation.
It is also likely that one drug may lead to development for resistance to other drug in the same class of drug or if a drug has same mechanism of action, then a resistance developed for one may cause a resistance to other drug too, this phenomenon is known as cross-resistance.
The similar phenomenon occurs in other microorganisms typically with development of antibiotic assay but they are very much controllable with other drugs.
Today a drug resistance is one of a biggest challenge in front of doctors treating HIV infection.
Now days some drug resistance assays are also available, which finds out the susceptibility of HIV virus present in some ones body for developing a drug resistance with genotypic and phenotypic analysis.
There are number of efforts going on to develop a vaccine against HIV virus but because of the frequent changes in genetic material , HIV virus develops capability to survive even after vaccination with vaccines so far developed, Still there are some encouraging results observed with neutralizing antibodies against HIV virus, which can be used concomitantly with chemotherapy.

What we should do to survive from HIV virus.
We always say over our blog that “its very easy to stay away from getting HIV infection, than providing some one a treatment for HIV infection, and choice is completely yours”! And it will save not only your life but it will save your family”!
It is a simple thing to stay away from HIV virus by adapting simple precautionary measures.
Avoid unprotected sex with unknown individual.
Show courage to say NO! for sex with unknown person. And save your and your families life, it is completely in your hand. One should always keep in mind that AIDS is a biggest killer today world wide, it do not understand boundaries of any nation.

Here we have given details of how HIV virus infection occurs and what are precautionary measures one should adopt to stay away from getting HIV infection, It is also important that one should teach his or her siblings and relatives and friends to adapt precautionary measures to
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Source:
http://www.niaid.nih.gov/topics/HIVAIDS/Documents/niaid_hvad_aa_fs.pdf

http://www.aidsinfonet.org/fact_sheets/view/126

http://aidsinfo.nih.gov/ContentFiles/ChangingMyHIVTreatmentRegimen_FS_en.pdf

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Last updated: 15-Nov-2011

Which foods a HIV positive individual should eat and which food HIV positive should avoid eating.

noreply@blogger.com (Martin) — Mon, 15 Nov 2010 11:10:00 +0000

Which foods a HIV positive individual should eat and which food HIV positive should avoid eating.
A HIV positive individual can eat all sorts of food.
It is found that in some individuals beta-carotine increased the cd4 receptor cells count , this requires to be proved in a clinical trial , but still if one eats carrot in his or her meal it will be bit healthier.
Avoid eating garlic in any form in cooked food or as a supplement , as it is known to interact with certain anti AIDS drugs , specially protease inhibitors.

Avoid smoking and eating or chewing tobacco , as this may develop drug resistance or increased hepatic metabolism of your drug rendering a drug no or less effective.

Source:
Garlic and protease inhibitor drugs

Beta Carotene in HIV infection

HIV and Smoking

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Last updated: 15-Nov-2010

Why HAART regimen of drugs is given ?

noreply@blogger.com (Martin) — Mon, 15 Nov 2010 11:08:00 +0000

Why HAART regimen of drugs is given ?

HIV virus is known to develop resistance to drugs very fast, so that the HIV virus can grow even after taking that a drug for which HIV virus developed resistance.Hence even if one class of drug develops resistance HIV virus is likely to be stopped from further growth by other class of drug and so on , but there are certain limitations of every class of drugs so that they are able to control multiplication of HIV virus till some steps but not at all steps .

Hence combining all drugs those drugs which are acting at different levels in life cycle of HIV virus are formed to make a combination that is able to stop HIV virus from growth at all possible steps in HIV virus life cycle.

Hence HAART is the main therapy today available for treatment for HIV infection.

Till today there is no vaccine available for treatment of HIV infection, until today vaccines developed against HIV virus could not prove its beneficial effects in clinical trials.

Source:
Highly Active Antiretroviral Therapy and all FDA approved drugs for HIV treatment

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Which are the currently available medicines for treating HIV infection ? What is HAART ?
noreply@blogger.com (Martin) — Mon, 15 Nov 2010 11:02:00 +0000

Which are the currently available medicines for treating HIV infection ? What is HAART ?
There are following class of drugs available so far for treatment of HIV infection.
HAART is made up of different kinds of drugs comprising from following categories:

1. Nucleoside Reverse Transcriptase Inhibitors (NRTIs)
2. Nonnucleoside Reverse Transcriptase Inhibitors (NNRTIs)
3. Protease Inhibitors
4. Fusion Inhibitors
5. Integrase Inhibitors
6. Entry Inhibitors
7. Combination Drugs

Here is the detailed list of drugs which are approved by US FDA.
These drugs are mentioned here just for the sec of education and purely for information purpose only , drugs are referred here for reference purpose only for research institutes ,universities and research scientists.

One should not take any drug without consulting his or her doctor , they (doctors) prescribe drugs keeping in view all the side effects and benefits of a drug if there are more harmful side effects which may prove fatal to a patient than actual benefit then such drugs are avoided , hence one should listen and follow doctors instruction regarding medication.

First Brand name is given and in the bracket generic name of the drug with its abbrivation is provided)
Nucleoside Reverse Transcriptase Inhibitors (NRTIs) ---
Combivir (Lamivudine and Zidovudine)
Emtriva (Emtricitabine FTC)
Epivir (Lamivudine 3TC)
Epzicom (Abacavir and Lamivudine)
Hivid (Zalcitabine Dideoxycytidine ddC )
Retrovir (Zidovudine AZT or Azidothymidine, ZDV)
Trizivir (Abacavir, Zidovudine and Lamivudine)
Truvada (Tenofovir Disoproxil and Emtricitabine )
Videx (Didanosine , ddl, Dideoxyinosine)
Videx EC (Enteric Coated Didanosine)
Viread (Tenofovir Disoproxil Fumarate, TDF )
Zerit (Stavudine d4T)
Ziagen (Abacavir Sulfate, ABC)

Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs)
Intelence (Etravirine)
Rescriptor (Delavirdine DLV)
Sustiva (Efavirenz)
Viramune (Nevirapine)

Protease Inhibitors
Agenerase (Amprenavir APV)
Aptivus (Tipranavir TPV)
Crixivan (Indinavir IDV, MK-639)
Fortovase (Saquinavir (no longer marketed))
Invirase (Saquinavir Mesylate SQV)
Kaletra (Lopinavir and Ritonavir LPV/RTV)
Lexiva (Fosamprenavir Calcium FOS-APV )
Norvir (Ritonavir RTV)
Prezista (Darunavir)
Reyataz (Atazanavir Sulfate ATV)
Viracept (Nelfinavir Mesylate NFV)

Fusion Inhibitors
Fuzeon (Enfuvirtide T-20 )This medicine is a shot.

Multi-Class Combination Drugs
Atripla (Efavirenz, Emtricitabine,and Tenofovir Disoproxil Fumarate)

Integrase Inhibitors
Isentress (Raltegravir)

*Entry Inhibitors
Selzentry (Maraviroc)

It is required to form a combination of drugs from almost all class of drugs listed above so that the virus multiplication and count is brought under control.
This is called Highly Active Antiretroviral Therapy. (HAART)

Source:
FDA approved drugs for HIV treatment

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Last updated: 15-Nov-2010

Treatment for HIV infection and AIDS

noreply@blogger.com (Martin) — Mon, 15 Nov 2010 10:51:00 +0000

Treatment for HIV infection and AIDS:
There is no cure for AIDS till today but continuous efforts are going on to develop a life saving treatment for AIDS. Also currently available antiretroviral drugs are very effective, a continuous monitoring of the CD4 count and early starting of medication ie. starting taking drugs as soon as one is found to be HIV positive, medicines taken on time without break definitely help to prevent the development of AIDS disease and its symptoms, remember HIV infection as such is not fatal but the symptoms that it develops are life threatening so starting medication early help a patient to live a quality life , as it lowers the rate of multiplication of HIV virus and prevent CD4 cell count going further below , and a person affected with HIV can live a good quality life.

There are very great hopes from gene therapy and stem cell therapy for HIV infection .
Drugs are likely to develop resistance , hence if there is a facility available then performing HIV drug Resistance Assay's help to select most effective drug for treatment.

It is good shair experience with friends and peoples from help groups , this reduces stress and related anxiety.

There is hope?
Yes there is hope for life !There are drugs now available , by taking these medicines on time without break one can live quality and longer life. May be till that time a life saving treatment is discovered and one get that facility .

Medicine those are available nowadays are able to reduce viral load in your body and prevent HIV virus from building up in your body. It is true that even after taking these medicine one carries virus in to his or her body , hence they are carrier of virus and they can give HIV virus infection.Individual with HIV infection is called HIV positive as the diagnostic test results are called positive if an individual is found to be infected with HIV virus.

Individual with HIV infection may require to take three or more different medicines daily.

Individual with HIV infection must take all given medicines regularly every day.

One should not stop taking medicines without talking to doctor.

Stopping taking medicine even for a day make result in to untoward effect that may result in to deterioration (weakening) of health of a HIV positive individual.

Source:

Highly Active Antiretroviral Therapy and all FDA approved drugs for HIV treatment

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Last updated: 15-Nov-2011

symptoms of HIV infection , early symptoms of HIV, symptoms of AIDS

noreply@blogger.com (Martin) — Mon, 15 Nov 2010 10:46:00 +0000

Which are early symptoms of HIV virus infection ?

After encountering HIV virus, for how many days HIV is not detected in Tests?

How much time it takes to get detected HIV positive after an exposure to HIV virus?

A test for HIV will not get detected positive immediately after an exposure , if a person has got exposure to HIV then it may take about two to twelve weeks to show positive results, it may also take about six months to get detected as HIV positive in the tests.

If a person is exposed to HIV virus by any way , it is better to start antiretroviral drug therapy immediately.

Also if one tests late after exposure to HIV virus and gets detected as HIV positive then the antiretroviral drugs are found less effective, hence one should start taking drugs early or immediately after exposure after consultation with your physician.

Symptoms of HIV infection , AIDS Symptoms.
The symptoms of AIDS are basically outcome of poor immune , or poor resistance to fight any incoming infection in to affected body , in individuals with healthy immune systems who are not infected their body is able to resist kill any incoming infectious bacteria and viruses.
In almost cases AIDS symptoms are infections caused by bacteria, viruses, fungi and parasites those are normally are in abundance around human body and normal human body controls
Opportunistic infections are most common in individuals affected with AIDS.Opportunistic infections affect almost every organ human body.
Individual with AIDS also have an increased risk of developing various disease like Kaposi's sarcoma, and lymphomas.

Individuals affected with AIDS shows systemic symptoms of infection as follows
Fevers, sweating particularly at night, swollen glands, chills, weakness, and weight loss.
Opportunistic infections that an AIDS patients may develop is the factor of kind of exposure to an infection.
Pulmonary infections
Pulmonary infections occur when the CD4 count is less than 200 cells per µL of blood.
Pneumocystis pneumonia is relatively rare in healthy, immunocompetent people, but common among HIV-infected individuals. It is caused by Pneumocystis jirovecii.
Tuberculosis
(TB) is a unique symptom of AIDS among the peoples infectected with HIV as TB bacteria is transmissible to immunocompetent people through the respiratory route, early-stage HIV dignosis is and strting a treatment is most important factor to avoid deths due to TB. TB is preventable with drug therapy .
Care should be taken in drug therapy so that multidrug resistance do not occure.
Tuberculosis with other HIV co-infection (TB/HIV) is one of the major problem.
Early-stage HIV infection (CD4 count >300 cells per µL), TB presents as a pulmonary disease.
and in advanced HIV infection, TB presents with extrapulmonary (systemic) disease a common feature. Symptoms are usually constitutional and symptoms are not localized to one particular site, also affects bone marrow, bone, urinary and gastrointestinal tracts, liver, regional lymph nodes, and the central nervous system
Gastrointestinal infections
Esophagitis , inflammation of lining of the lower side of the esophagus (gullet or swallowing tube leading to the stomach). In HIV infected peoples, Gastrointestinal infections are normally due to fungal (candidiasis) or viral (herpes simplex-1 or cytomegalovirus) infections. In rare cases, it could be due to mycobacteria.
chronic diarrhea in HIV infection is due to many possible causes, including common bacteria (Salmonella, Shigella, Listeria or Campylobacter) and parasite infestetion; and uncommon opportunistic infections such as cryptosporidiosis, microsporidiosis, Mycobacterium avium complex (MAC) and viruses,astrovirus, adenovirus, rotavirus and cytomegalovirus, (the latter as a course of colitis).
Diarrhea can be one of side effect of several drugs used to treat HIV infection, a side effect of antibiotics used to treat bacterial causes of diarrhea, or it may simply accompany HIV infection, particularly during primary HIV infection. It may also be (common for Clostridium difficile). In the later stages of HIV infection, diarrhea is thought to be a reflection of changes in the way the intestinal tract absorbs nutrients, and may be an important component of HIV-related weigh loss or muscle wash out.

Neurological and psychiatric considerations
HIV infection lead to a variety of neuropsychiatric sequelae, by infection of the nervous system by organisms which were once not harful, it may be a direct consequence of the illness.

Toxoplasma encephalitis

Toxoplasmosis is a disease caused by the parasite Toxoplasma gondii; it infects brain, resulting in to toxoplasma encephalitis, it also infect and cause disease in the eyes and lungs.
Cryptococcal meningitis is an infection of the meninx (the membrane covering the brain and spinal cord) by the fungus Cryptococcus neoformans. It causes fevers, headache, fatigue, nausea, and vomiting. individulas may also develop seizures and confusion.
Progressive multifocal leukoencephalopathy (PML) is a demyelinating disease, in which the gradual destruction of the myelin sheath covering the axons of nerve cells impairs the transmission of nerve impulses. It is caused by a virus called JC virus which occurs in 70% of the population in latent form, causing disease only when the immune system has been severely weakened, as is the case for AIDS patients.

AIDS dementia complex (ADC) is a metabolic encephalopathy induced by HIV infection . HIV infected brain macrophages and microglia cells are infected by HIV virus and secrete neurotoxins which are of both host as well as viral origin. Specific neurological impairments are manifested by cognitive, behavioral, and motor abnormalities that occur after years of HIV infection and are because of low CD4+ T cell levels and high plasma viral loads.
AIDS related mania is sometimes seen in patients with advanced HIV illness; it presents with more irritability and cognitive impairment and less euphoria than a manic episode associated with true bipolar disorder. Unlike the latter condition, it may have a more chronic course. This symptom is can be avoided if one takes proper medication .
Tumors and malignancies
Individuals infected with HIV virus show substantially increased incidence of several tumors and malignancies.
With todyas available new antiaids drugs and medicines which are so promising that if a patient is taking proper medication and his CD 4 count is not allowed to drop down , then all above symptoms are well controlled and life of HIV infected persone is extended to considerable value,

In contries where HAART is extensively used to treat AIDS, the incidence of many AIDS-related malignancies and symptoms has decreased.

Other infections
Opportunistic infection with Mycobacterium avium-intracellulare and cytomegalovirus (CMV).
CMV causes colitis, and CMV retinitis may cause blindness.
Penicilliosis caused by Penicillium marneffei is the third most common opportunistic infection (after extrapulmonary tuberculosis and cryptococcosis) in HIV-positive individuals .

Infection of Parvovirus B19 in AIDS patients , results in to anemia, this is difficult to distinguish from the side effects of antiAIDS drugs used to treat AIDS and HIV virus infection.

Source:
Signes and symptoms of AIDS and HIV infection--> http://www.aids.gov/hiv-aids-basics/hiv-aids-101/overview/signs-and-symptoms/

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Information on HIV virus

noreply@blogger.com (Martin) — Mon, 15 Nov 2010 10:39:00 +0000

Information on HIV virus, HIV virus infects human , how HIV virus reproduces in number (Replication of HIV virus)

Give information about HIV virus types
There are two species of HIV virus: HIV-1 and HIV-2.
HIV-1 is the virus that was initially discovered and as both LAV and HTLV-III (Human T-Lymphocytic virus Type iii ). It is considered more virulent and more infective, it is presently the major cause of HIV infections worldwide.

HIV-2 posses lower infectivity than compared to HIV-1 .

Give Brife information on HIV virus morphology( structure)
Structure of HIV virus
HIV virus is spherical in structure , measuring about 120 nm,It consist of two copies of RNA enclosed in to a capcid along with its enzyme system and proteins, the capsid is further surrounded by a lipid membrane made of P17 proteins.This inturn is surrounded by two layers phospholipids fatty molecules called as viral envelop.
There are about 70 protrusions of protiens from HIV virus envelop, these protrusions consists a tip called as cap and the stem which holds cap firmly placed on viral envelop.
Cap is made from glycoprotein (gp) 120 and stem is made from glycoprotein (gp) 41.These protiens help in attaching virus over t-lymphocytic cells and then injecting its RNA , in to human T lymphocytic cell .

Give Brife Information about Process of HIV virus infection
Entry of HIV virus in to cell
HIV virus gain entry in to human cells which are responsible for protecting human body from any form of incoming infection, that is by infecting CD4 T cells and macrophages
The process of gaining entry in to these cells involves adsorption of HIV virus over T cells surface receptor CD4 receptors this process involves adsorption of HIV viral glycoproteins over of lymphocytes , then HIV virus fuses with host cell by fusing its viral envelop with the human cell membrane and then HIV virus releases capsid into the lymphocytic cells.

In first step of HIV virus attachment over human lymphocytic cells , involves formation of bonding with viral protein arms called gp160 proteins with CD4 receptor and chemokine receptors of human lymphocytic cells.
At the same time gp120 proteins arm over HIV virus binds to integrin receptors which are a type of receptors over human cell that regulate attachment of cells with body tissue to facilitate cellular process , these receptors facilitate spreading of cell over the attaching surface , in this case it is HIV virus.

After attachment of gp120 protein arm of HIV virus , lymphocyte cell surface is aligned in proper orientation , so that the N terminal gp 41 protein of HIV virus easily penetrate in to human lymphocytic cell , this interaction or gp41 HIV viral protien facilitate in fusion of HIV viral capcid with human lyphocytic cells.
After fusion of HIV viral capcid , with human lymphocytic cell , HIV viral enzyme systems and HIV viral genetic material that is RNA , is released in to human cell cytoplasm.

While our body cells normal metabolic function RNA of this HIV virus is transcribed in to a single stranded DNA called as cDNA , which in tern is transcribed in to double stranded DNA that is now able to guide human host cell to synthesize HIV viral RNA and its proteins and enzymes which are then organized in to a new HIV virus , this process is called assembly and then this newly formed virus are released in to blood destroying the infected cell.

For this HIV DNA thus formed gets incorporated in to human DNA, and when ever human cell DNA functions normally to synthesize required proteins for human body function , it also synthesize new HIV viral particles by producing HIV viral proteins , RNA and enzyme system.

HIV virus also infect dendritic cells which are present in inner lining of the nose, lungs, stomach and intestines, and blood, and skin their main role is to capture an antigen and take it to lymph node and present this antigen to lymphocytic cells, which in tern result in development of immunity against the antigen.
Fasciculation and elongation protein zeta-1 (FEZ1) found in neurons prevents HIV virus from infecting neurons

Replication and transcription.
Human Imuno deficiency virus knows as HIV virus belongs to the genus Lentivirus, and Family Retroviridae.
HIV virus (Family Retroviridae) is a RNA virus, as against other types of virus which contains DNA .For process of reproduction of virus , it is required that it pass on its genetic information from parent virus to new virus . DNA contains genes, and gens are able to transfer its genetic information from parent to progeny, but HIV contains RNA it stores all genetic information over these RNA.

Hence to transfer its own genetic information from parent virus to new virus, RNA of HIV Virus develops a copy of a DNA, This process is known as reverse transcription, and it is facilitated by enzyme reverse transcriptase, the reverse transcription process and enzyme reverse transcriptase is so called reverse as the process is just reverse process compared to DNA virus, where a genetic information is transcribed from DNA through RNA.

The newly formed single stranded copy of DNA makes its complementary copy and forms a double stranded DNA, with the help of enzymes DNA polymerase.

Now this DNA copy of HIV virus gets incorporated in to human DNA of T-Lymphocytes, and when ever these T-Lymphocytes carry out the process of protein synthesis for them selves, they are also making the HIV virus proteins and RNA as that of parent HIV virus as the DNA of infected T-Lymphocytes contains DNA copy formed by HIV virus in the process of reverse transcription.
The enzyme responsible for integration of DNA copy formed by HIV virus in to human DNA of T-Lymphocytes are intercalase and integrase.

Steps in the HIV Replication Cycle1. HIV virus fusion with the surface of the host cell.
2. Entry of HIV virus RNA, integrase, reverse transcriptase, HIV virus other proteins in to host cell.
3. HIV virus DNA copy formed after action of reverse transcription.
4. Transportation of Viral DNA across human cell nucleus and intergradation in the host DNA.
5. Newly formed HIV virus RNA utilized as genomic RNA for making new HIV virus proteins.
6. Newly formed HIV virus RNA and proteins goes towards cell surface , a new HIV virus which is immature is formed.
7. HIV virus finaly developes in to complete assembly after enzyme protease forms individual HIV proteins.

What is AIDS?
HIV virus is infects human T-Cells which are known to impart immunity and protect human body from any sort of incoming infection, after infection with HIV virus, these cells count lowers down to such an extent that, the general microbial flora which all humans do harbor in their body, and is not harmful otherwise, becomes harmful and turns to be pathogenic (Harmful). This is the main cause which develops serious and life threatening complications in HIV virus infected individuals, thus develops in to the disease known as AIDS (Acquired immune deficiency syndrome).

When do AIDS disease occurs?
When a person is infected with HIV virus, there are chances of developing disease AIDS acquired immune deficiency syndrome. This disease is developed as a result of decline in CD4 cell count (below 200 / µL) as HIV virus destroys all of CD4 cells in our body.
Chances of development of AIDS disease can be minimized by starting early anti retroviral drug therapy , early treatment for HIV infection can save life of person to considerable amount of time there are peoples living for more that 15 years and more with HIV positive status , with anti retroviral drug therapy.

There is much more information on HIV virus new findings available on this blog.
Here are given details about symptoms of AIDS , all new symptoms of AIDS and HIV virus infection are updated.

Drug development against HIV virus , Drug Resistance assay's and analysis during drug development

Here is the latest development on treatment for HIV and AIDS
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Source:
Basic information about HIV and AIDS ==>http://www.cdc.gov/hiv/topics/basic/index.htm

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This website provideds complete information about hiv virus , hiv infection , early hiv symptoms , hiv treatment,hiv test and hiv testing centers, aids symptoms, symptoms of hiv immideately after infection.

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Following are the most read topic on this website you should find them on blog archive of this website
Stem cell treatment for AIDS

AIDS symptoms
SYMPTOMS OF HIV
HIV infection symptoms
Latest treatment for AIDS
How anti retroviral medicines are developed
How Chemotherapeutic drugs are developed to treat HIV virus infection
New drug developments against HIV Virus AIDS
Vaccines research for HIV AIDS Why it is difficult to develop a vaccine against HIV
Mother to child prevention of HIV virus infection.
HIV virus infection prevention and education blogger
Information about HIV Virus AIDS symptoms

Last updated: 15-Nov-2010

Information about HIV virus, information about AIDS (Acquired immuno deficiency syndrome)how HIV virus infects human , how HIV virus reproduces in number (Replication of HIV virus) AIDS symptoms

noreply@blogger.com (Martin) — Thu, 28 Oct 2010 20:06:00 +0000

Information on HIV virus, information about AIDS Symptom (Acquired immuno deficiency syndrome) how HIV virus infects human , how HIV virus reproduces in number (Replication of HIV virus) HIV infection symptoms

Give information about HIV virus types
There are two species of HIV virus: HIV-1 and HIV-2.
HIV-1 is the virus that was initially discovered and as both LAV and HTLV-III (Human T-Lymphocytic virus Type iii ). It is considered more virulent and more infective, it is presently the major cause of HIV infections worldwide.

HIV-2 posses lower infectivity than compared to HIV-1 .

Give Brife information on HIV virus morphology( structure)
Structure of HIV virus
HIV virus is spherical in structure , measuring about 120 nm,It consist of two copies of RNA enclosed in to a capcid along with its enzyme system and proteins, the capsid is further surrounded by a lipid membrane made of P17 proteins.This inturn is surrounded by two layers phospholipids fatty molecules called as viral envelop.
There are about 70 protrusions of protiens from HIV virus envelop, these protrusions consists a tip called as cap and the stem which holds cap firmly placed on viral envelop.
Cap is made from glycoprotein (gp) 120 and stem is made from glycoprotein (gp) 41.These protiens help in attaching virus over t-lymphocytic cells and then injecting its RNA , in to human T lymphocytic cell .

Give Brife Information about Process of HIV virus infection
Entry of HIV virus in to cell
HIV virus gain entry in to human cells which are responsible for protecting human body from any form of incoming infection, that is by infecting CD4 T cells and macrophages
The process of gaining entry in to these cells involves adsorption of HIV virus over T cells surface receptor CD4 receptors this process involves adsorption of HIV viral glycoproteins over of lymphocytes , then HIV virus fuses with host cell by fusing its viral envelop with the human cell membrane and then HIV virus releases capsid into the lymphocytic cells.

In first step of HIV virus attachment over human lymphocytic cells , involves formation of bonding with viral protein arms called gp160 proteins with CD4 receptor and chemokine receptors of human lymphocytic cells.
At the same time gp120 proteins arm over HIV virus binds to integrin receptors which are a type of receptors over human cell that regulate attachment of cells with body tissue to facilitate cellular process , these receptors facilitate spreading of cell over the attaching surface , in this case it is HIV virus.

After attachment of gp120 protein arm of HIV virus , lymphocyte cell surface is aligned in proper orientation , so that the N terminal gp 41 protein of HIV virus easily penetrate in to human lymphocytic cell , this interaction or gp41 HIV viral protien facilitate in fusion of HIV viral capcid with human lyphocytic cells.
After fusion of HIV viral capcid , with human lymphocytic cell , HIV viral enzyme systems and HIV viral genetic material that is RNA , is released in to human cell cytoplasm.

While our body cells normal metabolic function RNA of this HIV virus is transcribed in to a single stranded DNA called as cDNA , which in tern is transcribed in to double stranded DNA that is now able to guide human host cell to synthesize HIV viral RNA and its proteins and enzymes which are then organized in to a new HIV virus , this process is called assembly and then this newly formed virus are released in to blood destroying the infected cell.

For this HIV DNA thus formed gets incorporated in to human DNA, and when ever human cell DNA functions normally to synthesize required proteins for human body function , it also synthesize new HIV viral particles by producing HIV viral proteins , RNA and enzyme system.

HIV virus also infect dendritic cells which are present in inner lining of the nose, lungs, stomach and intestines, and blood, and skin their main role is to capture an antigen and take it to lymph node and present this antigen to lymphocytic cells, which in tern result in development of immunity against the antigen.
Fasciculation and elongation protein zeta-1 (FEZ1) found in neurons prevents HIV virus from infecting neurons

Replication and transcription.
Human Imuno deficiency virus knows as HIV virus belongs to the genus Lentivirus, and Family Retroviridae.
HIV virus (Family Retroviridae) is a RNA virus, as against other types of virus which contains DNA .For process of reproduction of virus , it is required that it pass on its genetic information from parent virus to new virus . DNA contains genes, and gens are able to transfer its genetic information from parent to progeny, but HIV contains RNA it stores all genetic information over these RNA.

Hence to transfer its own genetic information from parent virus to new virus, RNA of HIV Virus develops a copy of a DNA, This process is known as reverse transcription, and it is facilitated by enzyme reverse transcriptase, the reverse transcription process and enzyme reverse transcriptase is so called reverse as the process is just reverse process compared to DNA virus, where a genetic information is transcribed from DNA through RNA.

The newly formed single stranded copy of DNA makes its complementary copy and forms a double stranded DNA, with the help of enzymes DNA polymerase.

Now this DNA copy of HIV virus gets incorporated in to human DNA of T-Lymphocytes, and when ever these T-Lymphocytes carry out the process of protein synthesis for them selves, they are also making the HIV virus proteins and RNA as that of parent HIV virus as the DNA of infected T-Lymphocytes contains DNA copy formed by HIV virus in the process of reverse transcription.
The enzyme responsible for integration of DNA copy formed by HIV virus in to human DNA of T-Lymphocytes are intercalase and integrase.

What is AIDS?
HIV virus is infects human T-Cells which are known to impart immunity and protect human body from any sort of incoming infection, after infection with HIV virus, these cells count lowers down to such an extent that, the general microbial flora which all humans do harbor in their body, and is not harmful otherwise, becomes harmful and turns to be pathogenic (Harmful). This is the main cause which develops serious and life threatening complications in HIV virus infected individuals, thus develops in to the disease known as AIDS (Acquired immune deficiency syndrome).

When do AIDS disease occurs?
When a person is infected with HIV virus, there are chances of developing disease AIDS acquired immune deficiency syndrome. This disease is developed as a result of decline in CD4 cell count (below 200 / µL) as HIV virus destroys all of CD4 cells in our body.
Chances of development of AIDS disease can be minimized by starting early anti retroviral drug therapy , early treatment for HIV infection can save life of person to considerable amount of time there are peoples living for more that 15 years and more with HIV positive status , with anti retroviral drug therapy.

Which are early symptoms of HIV virus infection ?

After encountering HIV virus, for how many days HIV is not detected in Tests?

How much time it takes to get detected HIV positive after an exposure to HIV virus?

A test for HIV will not get detected positive immediately after an exposure , if a person has got exposure to HIV then it may take about two to twelve weeks to show positive results, it may also take about six months to get detected as HIV positive in the tests.

If a person is exposed to HIV virus by any way , it is better to start antiretroviral drug therapy immediately.

Also if one tests late after exposure to HIV virus and gets detected as HIV positive then the antiretroviral drugs are found less effective, hence one should start taking drugs early or immediately after exposure after consultation with your physician.

Symptoms of HIV infection , AIDS Symptoms.
The symptoms of AIDS are basically outcome of poor immune , or poor resistance to fight any incoming infection in to affected body , in individuals with healthy immune systems who are not infected their body is able to resist kill any incoming infectious bacteria and viruses.
In almost cases AIDS symptoms are infections caused by bacteria, viruses, fungi and parasites those are normally are in abundance around human body and normal human body controls
Opportunistic infections are most common in individuals affected with AIDS.Opportunistic infections affect almost every organ human body.
Individual with AIDS also have an increased risk of developing various disease like Kaposi's sarcoma, and lymphomas.

Individuals affected with AIDS shows systemic symptoms of infection as follows
Fevers, sweating particularly at night, swollen glands, chills, weakness, and weight loss.
Opportunistic infections that an AIDS patients may develop is the factor of kind of exposure to an infection.
Pulmonary infections
Pulmonary infections occur when the CD4 count is less than 200 cells per µL of blood.
Pneumocystis pneumonia is relatively rare in healthy, immunocompetent people, but common among HIV-infected individuals. It is caused by Pneumocystis jirovecii.
Tuberculosis
(TB) is a unique symptom of AIDS among the peoples infectected with HIV as TB bacteria is transmissible to immunocompetent people through the respiratory route, early-stage HIV dignosis is and strting a treatment is most important factor to avoid deths due to TB. TB is preventable with drug therapy .
Care should be taken in drug therapy so that multidrug resistance do not occure.
Tuberculosis with other HIV co-infection (TB/HIV) is one of the major problem.
Early-stage HIV infection (CD4 count >300 cells per µL), TB presents as a pulmonary disease.
and in advanced HIV infection, TB presents with extrapulmonary (systemic) disease a common feature. Symptoms are usually constitutional and symptoms are not localized to one particular site, also affects bone marrow, bone, urinary and gastrointestinal tracts, liver, regional lymph nodes, and the central nervous system
Gastrointestinal infections
Esophagitis , inflammation of lining of the lower side of the esophagus (gullet or swallowing tube leading to the stomach). In HIV infected peoples, Gastrointestinal infections are normally due to fungal (candidiasis) or viral (herpes simplex-1 or cytomegalovirus) infections. In rare cases, it could be due to mycobacteria.
chronic diarrhea in HIV infection is due to many possible causes, including common bacteria (Salmonella, Shigella, Listeria or Campylobacter) and parasite infestetion; and uncommon opportunistic infections such as cryptosporidiosis, microsporidiosis, Mycobacterium avium complex (MAC) and viruses,astrovirus, adenovirus, rotavirus and cytomegalovirus, (the latter as a course of colitis).
Diarrhea can be one of side effect of several drugs used to treat HIV infection, a side effect of antibiotics used to treat bacterial causes of diarrhea, or it may simply accompany HIV infection, particularly during primary HIV infection. It may also be (common for Clostridium difficile). In the later stages of HIV infection, diarrhea is thought to be a reflection of changes in the way the intestinal tract absorbs nutrients, and may be an important component of HIV-related weigh loss or muscle wash out.

Neurological and psychiatric considerations
HIV infection lead to a variety of neuropsychiatric sequelae, by infection of the nervous system by organisms which were once not harful, it may be a direct consequence of the illness.

Toxoplasma encephalitis

Toxoplasmosis is a disease caused by the parasite Toxoplasma gondii; it infects brain, resulting in to toxoplasma encephalitis, it also infect and cause disease in the eyes and lungs.
Cryptococcal meningitis is an infection of the meninx (the membrane covering the brain and spinal cord) by the fungus Cryptococcus neoformans. It causes fevers, headache, fatigue, nausea, and vomiting. individulas may also develop seizures and confusion.
Progressive multifocal leukoencephalopathy (PML) is a demyelinating disease, in which the gradual destruction of the myelin sheath covering the axons of nerve cells impairs the transmission of nerve impulses. It is caused by a virus called JC virus which occurs in 70% of the population in latent form, causing disease only when the immune system has been severely weakened, as is the case for AIDS patients.

AIDS dementia complex (ADC) is a metabolic encephalopathy induced by HIV infection . HIV infected brain macrophages and microglia cells are infected by HIV virus and secrete neurotoxins which are of both host as well as viral origin. Specific neurological impairments are manifested by cognitive, behavioral, and motor abnormalities that occur after years of HIV infection and are because of low CD4+ T cell levels and high plasma viral loads.
AIDS related mania is sometimes seen in patients with advanced HIV illness; it presents with more irritability and cognitive impairment and less euphoria than a manic episode associated with true bipolar disorder. Unlike the latter condition, it may have a more chronic course. This symptom is can be avoided if one takes proper medication .
Tumors and malignancies
Individuals infected with HIV virus show substantially increased incidence of several tumors and malignancies.
With todyas available new antiaids drugs and medicines which are so promising that if a patient is taking proper medication and his CD 4 count is not allowed to drop down , then all above symptoms are well controlled and life of HIV infected persone is extended to considerable value,

In contries where HAART is extensively used to treat AIDS, the incidence of many AIDS-related malignancies and symptoms has decreased.

Other infections
Opportunistic infection with Mycobacterium avium-intracellulare and cytomegalovirus (CMV).
CMV causes colitis, and CMV retinitis may cause blindness.
Penicilliosis caused by Penicillium marneffei is the third most common opportunistic infection (after extrapulmonary tuberculosis and cryptococcosis) in HIV-positive individuals .

Infection of Parvovirus B19 in AIDS patients , results in to anemia, this is difficult to distinguish from the side effects of antiAIDS drugs used to treat AIDS and HIV virus infection.

Treatment:
There is no cure for AIDS till today but continuous efforts are going on to develop a life saving treatment for AIDS. Also currently available antiretroviral drugs are very effective, a continuous monitoring of the CD4 count and early starting of medication ie. starting taking drugs as soon as one is found to be HIV positive, medicines taken on time without break definitely help to prevent the development of AIDS disease and its symptoms, remember HIV infection as such is not fatal but the symptoms that it develops are life threatening so starting medication early help a patient to live a quality life , as it lowers the rate of multiplication of HIV virus and prevent CD4 cell count going further below , and a person affected with HIV can live a good quality life.

There are very great hopes from gene therapy and stem cell therapy for HIV infection .
Drugs are likely to develop resistance , hence if there is a facility available then performing HIV drug Resistance Assay's help to select most effective drug for treatment.

It is good shair experience with friends and peoples from help groups , this reduces stress and related anxiety.

There is hope?
Yes there is hope for life !There are drugs now available , by taking these medicines on time without break one can live quality and longer life. May be till that time a life saving treatment is discovered and one get that facility .

Medicine those are available nowadays are able to reduce viral load in your body and prevent HIV virus from building up in your body. It is true that even after taking these medicine one carries virus in to his or her body , hence they are carrier of virus and they can give HIV virus infection.Individual with HIV infection is called HIV positive as the diagnostic test results are called positive if an individual is found to be infected with HIV virus.

Individual with HIV infection may require to take three or more different medicines daily.

Individual with HIV infection must take all given medicines regularly every day.

One should not stop taking medicines without talking to doctor.

Stopping taking medicine even for a day make result in to untoward effect that may result in to deterioration (weakening) of health of a HIV positive individual.

Which are the currently available medicines for treating HIV infection ? What is HAART ?
There are following class of drugs available so far for treatment of HIV infection.
HAART is made up of different kinds of drugs comprising from following categories:

1. Nucleoside Reverse Transcriptase Inhibitors (NRTIs)
2. Nonnucleoside Reverse Transcriptase Inhibitors (NNRTIs)
3. Protease Inhibitors
4. Fusion Inhibitors
5. Integrase Inhibitors
6. Entry Inhibitors
7. Combination Drugs

Here is the detailed list of drugs which are approved by US FDA.
These drugs are mentioned here just for the sec of education and purely for information purpose only , drugs are referred here for reference purpose only for research institutes ,universities and research scientists.

One should not take any drug without consulting his or her doctor , they (doctors) prescribe drugs keeping in view all the side effects and benefits of a drug if there are more harmful side effects which may prove fatal to a patient than actual benefit then such drugs are avoided , hence one should listen and follow doctors instruction regarding medication.

First Brand name is given and in the bracket generic name of the drug with its abbrivation is provided)
*Nucleoside Reverse Transcriptase Inhibitors (NRTIs) ---
Combivir (Lamivudine and Zidovudine)
Emtriva (Emtricitabine FTC)
Epivir (Lamivudine 3TC)
Epzicom (Abacavir and Lamivudine)
Hivid (Zalcitabine Dideoxycytidine ddC )
Retrovir (Zidovudine AZT or Azidothymidine, ZDV)
Trizivir (Abacavir, Zidovudine and Lamivudine)
Truvada (Tenofovir Disoproxil and Emtricitabine )
Videx (Didanosine , ddl, Dideoxyinosine)
Videx EC (Enteric Coated Didanosine)
Viread (Tenofovir Disoproxil Fumarate, TDF )
Zerit (Stavudine d4T)
Ziagen (Abacavir Sulfate, ABC)

*Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs)
Intelence (Etravirine)
Rescriptor (Delavirdine DLV)
Sustiva (Efavirenz)
Viramune (Nevirapine)

*Protease Inhibitors
Agenerase (Amprenavir APV)
Aptivus (Tipranavir TPV)
Crixivan (Indinavir IDV, MK-639)
Fortovase (Saquinavir (no longer marketed))
Invirase (Saquinavir Mesylate SQV)
Kaletra (Lopinavir and Ritonavir LPV/RTV)
Lexiva (Fosamprenavir Calcium FOS-APV )
Norvir (Ritonavir RTV)
Prezista (Darunavir)
Reyataz (Atazanavir Sulfate ATV)
Viracept (Nelfinavir Mesylate NFV)

*Fusion Inhibitors
Fuzeon (Enfuvirtide T-20 )This medicine is a shot.

*Multi-Class Combination Drugs
Atripla (Efavirenz, Emtricitabine,and Tenofovir Disoproxil Fumarate)

*Integrase Inhibitors
Isentress (Raltegravir)

*Entry Inhibitors
Selzentry (Maraviroc)

It is required to form a combination of drugs from almost all class of drugs listed above so that the virus multiplication and count is brought under control.
This is called Highly Active Antiretroviral Therapy. (HAART)

Why HAART regimen of drugs is given ?

HIV virus is known to develop resistance to drugs very fast, so that the HIV virus can grow even after taking that a drug for which HIV virus developed resistance.Hence even if one class of drug develops resistance HIV virus is likely to be stopped from further growth by other class of drug and so on , but there are certain limitations of every class of drugs so that they are able to control multiplication of HIV virus till some steps but not at all steps .

Hence combining all drugs those drugs which are acting at different levels in life cycle of HIV virus are formed to make a combination that is able to stop HIV virus from growth at all possible steps in HIV virus life cycle.

Hence HAART is the main therapy today available for treatment for HIV infection.

Till today there is no vaccine available for treatment of HIV infection, until today vaccines developed against HIV virus could not prove its beneficial effects in clinical trials.

Which foods a HIV positive individual should eat and which food HIV positive should avoid eating.
A HIV positive individual can eat all sorts of food.
It is found that in some individuals beta-carotine increased the cd4 receptor cells count , this requires to be proved in a clinical trial , but still if one eats carot in his or her meal it will be bit healthear.
Avoid eating garlic in any form in cooked food or as a suppliment , as it is known to interact with certain anti AIDS drugs , specialy protease inhibitors.

Avoid smoking and eating or chewing tobacoo , as this may develop drug resistance or increased hepatic metabolism of your drug rendering a drug no or less effective.

Why drugs available against HIV are not effective to the level which can save life?
Why there is no vaccines against AIDS is developed yet?

HIV virus multiplies with a great speed, and that is one of the reason that , there occurs lot of changes in genetic material of HIV virus that is a change in gene occurs which is called as mutation , after a mutation , the virus in which mutation takes place gives rise to a different virus that has very different genetic combination .
This is one of reason that HIV virus develops Drug Resistance against a particular drug .
That means a drug which was active against the HIV virus is not so active now against newly aroused HIV virus after mutation.
It is also likely that one drug may lead to development for resistance to other drug in the same class of drug or if a drug has same mechanism of action, then a resistance developed for one may cause a resistance to other drug too, this phenomenon is known as cross-resistance.
The similar phenomenon occurs in other microorganisms typically with development of antibiotic assay but they are very much controllable with other drugs.
Today a drug resistance is one of a biggest challenge in front of doctors treating HIV infection.
Now days some drug resistance assays are also available, which finds out the susceptibility of HIV virus present in some ones body for developing a drug resistance with genotypic and phenotypic analysis.
There are number of efforts going on to develop a vaccine against HIV virus but because of the frequent changes in genetic material , HIV virus develops capability to survive even after vaccination with vaccines so far developed, Still there are some encouraging results observed with neutralizing antibodies against HIV virus, which can be used concomitantly with chemotherapy.

What we should do to survive from HIV virus.
We always say over our blog that “its very easy to stay away from getting HIV infection, than providing some one a treatment for HIV infection, and choice is completely yours”! And it will save not only your life but it will save your family”!
It is a simple thing to stay away from HIV virus by adapting simple precautionary measures.
Avoid unprotected sex with unknown individual.
Show courage to say NO! for sex with unknown person. And save your and your families life, it is completely in your hand. One should always keep in mind that AIDS is a biggest killer today world wide, it do not understand boundaries of any nation.

Here we have given details of how HIV virus infection occurs and what are precautionary measures one should adopt to stay away from getting HIV infection, It is also important that one should teach his or her siblings and relatives and friends to adapt precautionary measures to

Who discovered HIV virus and tests for diagnosis of HIV infection?

HIV virus AIDS history. In 1981 AIDS disease was first identified, as a disease that is life threatening.

Dr Gallo and Montagnier discovered virus that causes AIDS as HIVvirus.
In 1983 HIV virus was first grown by Dr Gallo and Montagnier in vitro , in a laboratory
In 1985 the first commercial test to detect HIV virus was developed.

Dr Robert C. Gallo. Who worked for National Institutes of Health's National Cancer Institute, USA, till 1996 as head of Laboratory of Tumor Cell Biology, he is now a director of The Institute of Human Virology. University of Maryland School of Medicine, Baltimore

Dr Robert C. Gallo also discovered retroviruses HTLV -1 and HTLV-11 virus that causes cancers , initially it was said that HTLV virus was responsible for AIDS later it was demonstrated by Dr Gallo that (Human immune deficiency virus) HIV virus is responsible for AIDS , this discovery was very important point in developing the test for diagnosis for HIV infection, diagnosis test was also been developed by Dr Robert C. Gallo.

In 1976 Dr Robert C. Gallo and his colleagues discovered Interleukin-2, a growth regulating substance which is now is used in treatment of certain therapy in some cancer.

Dr Gallo is a great human being who has served for well being of mankind, decided to become a researcher in medicine after he lost his 8 year old sister to cancer when he was a young boy.

Mother to child HIV virus transmission

If a mother is HIV positive then there are high chances that her baby too gets HIV virus infection, most often HIV infection is passed on from mother to child during delivery, when baby comes in contact with mother’s blood, other route for infection is breast feeding. HIV virus also get transmitted from mother to her child through breast milk .Hence following precautions are required to take.
1.HARAT regimen of drug during pregnancy to reduce HIV virus load.
2.Avoiding breast feeding .(Its an critical issue as mothers milk too is essential) some alternate infant feed formulas should be tried , or other nursing mothers milk should be provided to infant.)
3.New born infants too are given antiretroviral drug treatments.

There is much more information on HIV virus new findings available on this blog.
Here are given details about symptoms of AIDS , all new symptoms of AIDS and HIV virus infection are updated.

Drug development against HIV virus , Drug Resistance assay's and analysis during drug development

Here is the latest development on treatment for HIV and AIDS

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Source:
Basic information about HIV and AIDS ==>http://www.cdc.gov/hiv/topics/basic/index.htm

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Following are the most read topic on this website you should find them on blog archive of this website
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AIDS symptoms
SYMPTOMS OF HIV
HIV infection symptoms
Latest treatment for AIDS
How anti retroviral medicines are developed
How Chemotherapeutic drugs are developed to treat HIV virus infection
New drug developments against HIV Virus AIDS
Vaccines research for HIV AIDS Why it is difficult to develop a vaccine against HIV
Mother to child prevention of HIV virus infection.
HIV virus infection prevention and education blogger

Information about HIV Virus AIDS symptoms

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Last updated 28-Oct-2010

NEW DRUG DEVELOPMENT (ANTI RETROVIRAL HIV) AND CONSIDERATIONS OF DRUG RESISTANCE TESTING IN HIV

noreply@blogger.com (Martin) — Thu, 28 Oct 2010 19:23:00 +0000

NEW DRUG DEVELOPMENT (ANTI RETROVIRAL HIV) AND CONSIDERATIONS OF DRUG RESISTANCE TESTING IN HIV .

Why there is no drug that is completely effective against HIV virus infection , why these HIV virus get resistance very quikely to a perticular drug , not only that it also develops cross resistance to other drug belongin to same group.

We are provinding here a complete guide for developing new drug after studing its for resistance .

Why there is no effective drug for treating HIV infection , whey HIV virus develop resistance with these drugs?

Because of high rate of replication of HIV virus (10rest to 9 , –to-- 10 rest to 10 virions per person per day) and error-prone polymerase, HIV can easily develop mutations that alter susceptibility to antiretroviral drugs. As a result, the emergence of resistance to one or more antiretroviral drugs is one of the more common reasons for therapeutic failure in the treatment of HIV. In addition, the emergence of resistance to one antiretroviral drug sometimes confers a reduction in or a loss of susceptibility to other or all drugs of the same class.
The application of laboratory technologies, such as gene amplification, automated nucleic acid sequencing, and nucleic acid hybridization, and the availability of recombinant viruses for testing phenotypic susceptibility have permitted advances in HIV resistance testing. Many clinicians and investigators are currently using these technologies in the clinical management of HIV. However, performance characteristics (e.g., sensitivity, specificity, and reproducibility) for many of the assays in investigational use have not been fully established. In addition, the clinical significance of many mutations or mutational patterns has not been defined completely for many antiretroviral drugs. Likewise, the quantitative relationship between reductions of cell culture susceptibility and loss of clinical activity has not been established for most drugs. Consequently, many of the current package inserts are deficient in the amount and type of resistance data describing the utility of a drug in the setting of resistance or reduced susceptibility.
Despite limitations of resistance assays and their interpretation, several randomized controlled studies have demonstrated that virologic outcome, at least over the short term, may be improved when genotypic or phenotypic data are used to guide choice of drug regimens in patients with loss of virologic response to prior regimens (Baxter et al. 2000; Cohen et al. 2002; Durant et al. 1999; Melnick et al. 2000; Meynard et al. 2000; Tural et al. 2002). It is recommended that characterization of resistance and cross-resistance be a part of antiretroviral drug development so that clinically relevant information is available at the time of approval. An efficient way to accomplish the goal of having clinically relevant information available at the time of approval is to include resistance testing in all phases of drug development. As discussed below, assessment of resistance should not be delayed until phase 3 or post-approval. We recommend that, before or during phase 1 and phase 2 studies, investigators begin assessing the potential of a drug to select resistant viruses and the drug’s activity against HIV isolates resistant to other antiretroviral agents. During early development, a wide range of doses should be evaluated and pharmacokinetic data should be collected, providing information to investigate the relationship between drug exposure and resistance

Optimally, a comprehensive evaluation of a new drug’s resistance and cross-resistance profile will promote more rational use of antiretroviral drug combinations in the future.
Once drug resistance factors are overcome , we will be able to provide a life saving treatment for HIV positive peoples , so far it is not completely achived , but i am going to present you a nice article , that will cover , the detailed road map or guidelines for developing a drug after scrining its resisntance, following are the topic which are descussed in detailes.

IV. NONCLINICAL STUDIES
A. Mechanism of Action
B. Antiviral Activity in Cell Culture
C. Cytotoxicity and Therapeutic Indexes
D. Protein Binding
E. Selection of Drug-Resistant HIV-1 Variants in Cell Culture
1. Genotype
2. Phenotype
F. Cross-Resistance
G. Characterization of Genotypic and Phenotypic Assays
1. Genotypic Assays
2. Phenotypic Assays
V. CLINICAL STUDIES: USE OF RESISTANCE TESTING IN CLINICAL PHASES OF DRUG DEVELOPMENT
A. General Considerations
B. Data Collection
C. Methods and Types of Analyses
1. Baseline Genotype and Virologic Response
2. Development of HIV Mutations
3. Baseline Phenotype and Virologic Response
4. Genotypic and Phenotypic Correlations: Changes in Susceptibility from Baseline
5. Cross-Resistance
6. Additional Analyses
D. Other Considerations
1. Role for Supporting Initial Activity and Dose-Finding Studies
2. Data Collection from Dose-Finding Trials
3. Use of Resistance Data to Establish an Indication
4. Use of Resistance Data for Study Enrollment Criteria, Background Regimen Selection, and Stratification Factors
5. Nonclade B Subtypes
E. Monitoring during Phase 4

REGULATORY REQUIREMENTS FOR SUBMITTING HIV RESISTANCE DATA

SUMMARY
Resistance analyses provide information regarding which mutations may have an effect on the therapeutic success of a given antiretroviral drug product. Such information potentially can be included in drug labeling to facilitate appropriate prescribing of products and to maximize the chance for therapeutic success.

Accessory or compensatory mutation:
A mutation that by itself does not confer a decrease in susceptibility to antiretroviral agents. Accessory or compensatory mutations can augment key mutations and, perhaps, fitness mutations.

Fitness mutation: An amino acid change that compensates for the reduced virus growth resulting from a drug resistance-conferring mutation.

Key mutation: A treatment-selected amino acid change that can cause a decrease in susceptibility to one or more antiretroviral agents of the same class.

Polymorphism: Natural variation in the HIV-1 genome.

Source:

Drug Resistance Assay and Antiretroviral drug development guidance--->
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071173.pdf

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Last Updated : 28-Oct-2010

REGULATORY REQUIREMENTS FOR SUBMITTING HIV RESISTANCE DATA

noreply@blogger.com (Martin) — Thu, 28 Oct 2010 19:13:00 +0000

REGULATORY REQUIREMENTS FOR SUBMITTING HIV RESISTANCE DATA
Sponsors are required to use the following sample format for submitting HIV resistance data to FDA.
One dataset combines patient data, endpoint data, genotypic data, and phenotypic data. There are a number of ways datasets can be subdivided (i.e., by clinical study, baseline isolates, or virologic failure isolates) and this should be discussed with the division before submission.
For each study, we recommend constructing datasets as SAS transport files containing the following information:
• One record (row) per patient per isolate (e.g., baseline, failure, and other time points).
• Data in columns (with suggested column headings shown below)4 on all isolates.
• Genotypic data should be provided on the corresponding record for each patient isolate for baseline isolates of all patients in treatment-experienced studies and the endpoint isolates of virologic failures and discontinuations in all studies.5 In treatment-naïve studies, a baseline sample should be collected and stored from all patients for future phenotypic and genotypic analysis of virologic failures.
• Phenotypic data should be provided on the corresponding record for each patient isolate for baseline isolates and the endpoint isolates of virologic failures and discontinuations.5 In treatment-experienced studies, it is recommended that baseline phenotypic data be obtained for all patients.

The specific criteria for defining virologic failures should be discussed with the division and may include multiple primary and secondary protocol endpoints. The endpoints for clinical virologic and resistance outcome analyses should be consistent.
Information to Include with Suggested Column Headings4
I. Patient Data:
• Patient identification number (ID number should be unique for all studies)
• Isolate (e.g., baseline, week 24, week 48, discontinuation. Multiple isolates should be numbered.)
• Date of isolate
• Study day (number of days since the patient started the study product)
• Previous therapeutic products where available
• Treatment group
• Censored for analysis (yes or no)
II. Endpoint Data:
• HIV RNA (copies/mL) at baseline (viral loads less than LLOQ should be listed as “ • HIV RNA (copies/mL) at predefined time points (e.g., week 24 and week 48), one column for each time point including baseline (i.e., the viral load throughout the course of the study is provided for each sample)
• HIV RNA (copies/mL) at other times (e.g., loss of virologic response or discontinuation because of adverse event)
• Endpoint assessment (e.g., mean log change in viral load from baseline)
• Other endpoint assessments (e.g., DAVG)
• Indication of data were censored for reasons other than virologic failure (e.g., discontinuation because of adverse event)
• Outcome (i.e., responder, virologic failure, discontinuation while suppressed, discontinuation before achieving viral suppression)
• Reason for discontinuation (i.e., adverse event, pregnancy) or failure (i.e., never suppressed, rebound)
• HIV RNA (copies/ml) from additional time points can be included

III. Genotypic Data:

Clade
• Genotype for the RT, protease, and gp160 (for products targeting entry only), one amino acid per column with the WT amino acid as column heading. Changes from WT standard sequence indicated (i.e., blanks indicate no change).
• Column with total number of PI mutations in patient isolate (for baseline and endpoint isolates). The specific mutations to include should be discussed with the division in advance.
• Column with total number of NRTI mutations in patient isolate (for baseline and endpoint isolates). The specific mutations to include should be discussed with the division in advance.
• Column with total number of NNRTI mutations in patient isolate (for baseline and endpoint isolates). The specific mutations to include should be discussed with the division in advance.
Example (Table A highlights how genotype information can be displayed, but does not include all column headings previously suggested.)

IV. Protease Cleavage Sites (for protease inhibitors only):
• NC/p1 Gag cleavage sites: show amino acid and position of cleavage site of WT in column headings (as above for genotype) and indicate amino acid change if mutant
• p1/p6 Gag cleavage sites: show amino acid and position of cleavage site of WT in column headings (as above for genotype) and indicate amino acid change if mutant
V. Phenotypic Data:

1. Information on the investigational product
• Baseline EC50 value for investigational product
• Baseline EC50 value of reference strain for investigational product
• Fold resistant change of baseline EC50 value compared to EC50 value of reference strain of investigational product
• EC50 value at time of endpoint assessment or failure for investigational product
• Fold change in EC50 value at time of endpoint assessment or failure compared to reference strain for investigational product
• Fold change in EC50 value at time of endpoint assessment or failure compared to baseline for investigational product
• Replication capacity (if available)

2. Information on approved and other investigational anti-HIV products (if available) in the same class
• Fold change in EC50 value of baseline compared to reference strain for each of the approved and other investigational anti-HIV products (if available)
• Fold change in EC50 value at time of endpoint assessment or failure compared to reference strain for each of the approved and other investigational anti-HIV products (if available)
• Fold change in EC50 value at time of endpoint assessment or failure compared to baseline for each of the approved and other investigational anti-HIV products (if available)

3. Information on approved and other investigational products (if available) outside the investigational product’s class with same target protein (e.g., NRTIs and NNRTIs)
• Fold change in EC50 value of baseline compared to reference strain for approved and other investigational products (if available) outside the investigational product’s class
• Fold change in EC50 value at time of endpoint assessment or failure compared to reference strain for each of the approved and other investigational products (if available) outside the investigational product’s class
• Fold change in EC50 value at time of endpoint assessment or failure compared to baseline for each of the approved and other investigational products (if available) outside the investigational product’s class

4. Information on other antiretroviral products in the regimen
• Fold change in EC50 value of baseline compared to reference strain for other antiretroviral products in the regimen, one column per product
• Fold change in EC50 value at time of endpoint assessment or failure compared to reference strain for other antiretroviral products in the regimen, one column per product
• Fold change in EC50 value at time of endpoint assessment or failure compared to baseline for other antiretroviral products in the regimen, one column per product
Example (Table B highlights how phenotype information can be displayed, but does not include all column headings previously suggested.)

VI. Co-Receptor Usage (for all agents targeting co-receptors):
• Co-receptor usage of baseline isolates. Indicate R5, X4, D for dual-tropic, M for mixed-tropic, or D/M if the assay cannot distinguish between dual or mixed, in a column.
• Baseline R5 tropism assay value (e.g., RLUs).
• Baseline X4 tropism assay value (e.g., RLUs).

Co-receptor usage of virologic failures and end-of-study isolates (on therapy). Indicate R5, X4, D for dual-tropic, M for mixed-tropic, or D/M if the assay cannot distinguish between dual or mixed, in a column.
• R5 tropism assay value at failure or end of study (e.g., RLUs).
• X4 tropism assay value at failure or end of study (e.g., RLUs).
VII. Therapeutic Drug Monitoring Data (when available):
• Patient’s Cmin
• Serum adjusted IQ (inhibitory quotient = Cmin/serum adjusted EC50 value)

IV. NONCLINICAL STUDIES
A. Mechanism of Action
B. Antiviral Activity in Cell Culture
C. Cytotoxicity and Therapeutic Indexes
D. Protein Binding
E. Selection of Drug-Resistant HIV-1 Variants in Cell Culture
1. Genotype
2. Phenotype
F. Cross-Resistance
G. Characterization of Genotypic and Phenotypic Assays
1. Genotypic Assays
2. Phenotypic Assays
V. CLINICAL STUDIES: USE OF RESISTANCE TESTING IN CLINICAL PHASES OF DRUG DEVELOPMENT
A. General Considerations
B. Data Collection
C. Methods and Types of Analyses
1. Baseline Genotype and Virologic Response
2. Development of HIV Mutations
3. Baseline Phenotype and Virologic Response
4. Genotypic and Phenotypic Correlations: Changes in Susceptibility from Baseline
5. Cross-Resistance
6. Additional Analyses
D. Other Considerations
1. Role for Supporting Initial Activity and Dose-Finding Studies
2. Data Collection from Dose-Finding Trials
3. Use of Resistance Data to Establish an Indication
4. Use of Resistance Data for Study Enrollment Criteria, Background Regimen Selection, and Stratification Factors
5. Nonclade B Subtypes
E. Monitoring during Phase 4

REGULATORY REQUIREMENTS FOR SUBMITTING HIV RESISTANCE DATA

SUMMARY

There is much more information on HIV virus new findings available on this blog.
Here are given details about symptoms of AIDS , all new symptoms of AIDS and HIV virus infection are updated.

Here is the latest development on treament for HIV and AIDS

------------------------------------------------------------------------------------------------------------
This website provideds complete information about hiv virus , hiv infection , early hiv symptoms , hiv treatment,hiv test and hiv testing centers, aids symptoms, symptoms of hiv immideately after infection.
------------------------------------------------------------------------------------------------------------

Following are the most read topic on this website you should find them on blog archive of this website
Stem cell treatment for AIDS
AIDS symptoms
SYMPTOMS OF HIV
HIV infection symptoms
Latest treatment for AIDS
How anti retroviral medicines are developed
How Chemotherapeutic drugs are developed to treat HIV virus infection
New drug developments against HIV Virus AIDS
Vaccines research for HIV AIDS Why it is difficult to develop a vaccine against HIV
Mother to child prevention of HIV virus infection.
hiv virus infection prevention and education bloggers

Information about HIV Virus AIDS symptoms

Source:
Drug Resistance Assay and Antiretroviral drug development guidance--->
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071173.pdf

========================================
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good manufacturing practices

Pharma guidelines

FDA guidelines
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Last updated: 28-Oct-2010

DRUG RESISTANCE TESTING NEW DRUG DEVELOPMENT (ANTI RETROVIRAL HIV) Other Considerations

noreply@blogger.com (Martin) — Thu, 28 Oct 2010 19:02:00 +0000

DRUG RESISTANCE TESTING NEW DRUG DEVELOPMENT (ANTI RETROVIRAL HIV)Other Considerations
1. Role for Supporting Initial Activity and Dose-Finding Studies
Primary objectives of initial clinical studies in HIV-infected patients should be to establish that the new investigational agent has anti-HIV activity, to determine the magnitude of that effect, and to determine the most active dose that can be taken forward in larger studies. Often, studies that incorporate short periods of monotherapy (e.g., less than or equal to 2 weeks) or functional monotherapy (when a drug is added to a failing but stable regimen) have been helpful in accomplishing these objectives. Compared to combination studies, such protocols can more clearly delineate the effect of the drug of interest. However, resistant viruses sometimes emerge rapidly for certain drugs, such that periods of monotherapy can jeopardize a patient’s future therapeutic options. Thus, some drugs are not candidates for use in monotherapy trials, including trials of short duration. Drugs for which a single mutation is easily selected and able to confer large reductions in susceptibility to the new drug and other drugs of the same class should not be studied as monotherapy, particularly in treatment-naïve individuals. Data from cell culture resistance studies, along with pharmacokinetic and safety data, should be used to determine whether a new drug could be safely administered as a single agent for limited periods of time.
2. Data Collection from Dose-Finding Trials
Sponsors should collect baseline genotype and phenotype information in HIV-infected patients who participate in pharmacokinetic and dose-finding studies. As stated previously, we encourage sponsors to analyze baseline resistance information and outcome in treatment-experienced patients. Analysis of baseline resistance and virologic outcome data in treatment-naïve patients may not be routinely needed; however, analysis of this information may be helpful to interpret unexpected virologic results. Current evidence indicates virologic response is better when drug levels can be maintained some increment above the serum-adjusted EC50 value (see section III, HIV Resistance Testing — General). Study patients with baseline resistance mutations may require higher drug concentrations of the antiretroviral drug to achieve an antiviral response that is comparable to that in patients with WT virus. Patients with particular genotypes and/or phenotypes of interest should be prospectively identified for inclusion in dose-ranging studies.
3. Use of Resistance Data to Establish an Indication
The amount of evidence sufficient to characterize a drug’s general resistance profile and the amount of data to support a specific efficacy claim against a particular resistant strain of HIV are not always the same. Well-controlled, randomized, prospective trials are preferred when attempting to develop a drug product to obtain a specific indication for use in a select group of patients with a particular resistance profile at baseline or antiretroviral treatment history. The amount of evidence sufficient to establish an efficacy claim in a specific patient population will be substantial, and studies of small numbers of patients are unlikely to accomplish this goal. Sponsors are encouraged to discuss their development plans with the division in advance. In addition, resistance data also can be considered for usage statements in a package insert.
4. Use of Resistance Data for Study Enrollment Criteria, Background Regimen Selection, and Stratification Factors
As mentioned earlier, resistance testing at baseline can be helpful in selecting antiretroviral-experienced study patients with particular resistance profiles. For example, to evaluate the efficacy of a new NNRTI in patients who have failed previous NNRTI regimens, sponsors can elect to enroll patients with confirmed genotypic and/or phenotypic NNRTI resistance. We strongly encourage sponsors to use all available phase 1 and phase 2 and nonclinical data to define which mutation or mutations adversely affect response rate. Early determination of the effect of baseline genotype and phenotype for new investigational agents can be important for patient selection into phase 3 clinical trials, thereby restricting specific mutational patterns or limiting the number of mutations to ensure all patients, regardless of randomized treatment, have a reasonable chance of virologic response.
Some studies evaluate a new drug combined with an optimized background, meaning that the concomitantly administered antiretrovirals were chosen based on data from resistance testing. For trials that include an optimized background regimen, genotypic and/or phenotypic resistance testing is used to guide the selection of the background antiretroviral regimen. In addition, some studies have used genotypic and/or phenotypic susceptibility scores to quantify the number of drugs to which a patient may still be susceptible. Sponsors also can consider using an external expert committee to aid in the selection of background regimen, especially for patients with limited therapeutic options.
Baseline resistance testing also can be used to stratify patients. Rationale for specific stratification factors should be discussed with the division in advance.
5. Nonclade B Subtypes
Sponsors are also encouraged to evaluate baseline resistance data and response and the development of resistance in patients with nonclade B viruses versus clade B viruses. Since many sponsors are conducting global development plans and it is unknown if different HIV subtypes develop resistance via different pathways, these data will add to the overall characterization of an investigational drug’s resistance profile (Hirsch et al. 2003).

IV. NONCLINICAL STUDIES
A. Mechanism of Action
B. Antiviral Activity in Cell Culture
C. Cytotoxicity and Therapeutic Indexes
D. Protein Binding
E. Selection of Drug-Resistant HIV-1 Variants in Cell Culture
1. Genotype
2. Phenotype
F. Cross-Resistance
G. Characterization of Genotypic and Phenotypic Assays
1. Genotypic Assays
2. Phenotypic Assays
V. CLINICAL STUDIES: USE OF RESISTANCE TESTING IN CLINICAL PHASES OF DRUG DEVELOPMENT
A. General Considerations
B. Data Collection
C. Methods and Types of Analyses
1. Baseline Genotype and Virologic Response
2. Development of HIV Mutations
3. Baseline Phenotype and Virologic Response
4. Genotypic and Phenotypic Correlations: Changes in Susceptibility from Baseline
5. Cross-Resistance
6. Additional Analyses
D. Other Considerations
1. Role for Supporting Initial Activity and Dose-Finding Studies
2. Data Collection from Dose-Finding Trials
3. Use of Resistance Data to Establish an Indication
4. Use of Resistance Data for Study Enrollment Criteria, Background Regimen Selection, and Stratification Factors
5. Nonclade B Subtypes
E. Monitoring during Phase 4

REGULATORY REQUIREMENTS FOR SUBMITTING HIV RESISTANCE DATA

SUMMARY

Source:

Drug Resistance Assay and Antiretroviral drug development guidance--->
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071173.pdf

There is much more information on HIV virus new findings available on this blog.
Here are given details about symptoms of AIDS , all new symptoms of AIDS and HIV virus infection are updated.

Here is the latest development on treament for HIV and AIDS

------------------------------------------------------------------------------------------------------------
This website provideds complete information about hiv virus , hiv infection , early hiv symptoms , hiv treatment,hiv test and hiv testing centers, aids symptoms, symptoms of hiv immideately after infection.------------------------------------------------------------------------------------------------------------

Following are the most read topic on this website you should find them on blog archive of this website
Stem cell treatment for AIDS
AIDS symptoms
SYMPTOMS OF HIV
HIV infection symptoms
Latest treatment for AIDS
How anti retroviral medicines are developed
How Chemotherapeutic drugs are developed to treat HIV virus infection
New drug developments against HIV Virus AIDS
Vaccines research for HIV AIDS Why it is difficult to develop a vaccine against HIV
Mother to child prevention of HIV virus infection.
hiv virus infection prevention and education bloggers

Information about HIV Virus AIDS symptoms

Last updated : 28-Oct-2010

DRUG RESISTANCE TESTING NEW DRUG DEVELOPMENT (ANTI RETROVIRAL HIV) Methods and Types of Analyses Development of HIV Mutations

noreply@blogger.com (Martin) — Thu, 28 Oct 2010 18:56:00 +0000

2. Development of HIV Mutations

We strongly recommend genotypic testing on all patients who meet the protocol-defined definition of a lack or loss of virologic response, preferably while on study drug or as soon as possible after discontinuation of study drug. Studies have shown WT virus may outgrow resistant HIV strains in the absence of selective drug pressure. For this reason, it can be useful to collect and store samples for resistance testing at the same time points HIV RNA testing are done. These samples can provide important information on the development of resistance, especially for drugs that may have more than one possible resistance pathway.
The proportion of patients who develop any nucleoside analogue reverse transcriptase inhibitor- (NRTI), nonnucleoside reverse transcriptase inhibitor- (NNRTI), or PI-associated mutation and the time to development of these mutations (measured as time to virologic failure) should be presented. Both primary and secondary mutations should be evaluated. For example, for patients receiving a new PI, it is important to evaluate the development of primary and secondary PI mutations along with any other changes in the PR (protease) and RT gene, when applicable. It is also important to assess the genotypic basis of drug susceptibility changes attributable to extragenic sites, such as the protease cleavage sites.

3. Baseline Phenotype and Virologic Response
Analyses also should be conducted to define the decrease in phenotypic susceptibility that adversely affects virologic response (i.e., susceptibility breakpoints). Rather than a single breakpoint, we encourage sponsors to explore incremental subgroups associated with maximal, reduced, or minimal response rates. However, we recognize a single breakpoint may be more appropriate for some drugs. Importantly, the breakpoints determined for a given study are not meant to represent definitive clinical susceptibility breakpoints for all patient populations. Often the data in an initial NDA submission are based on a select patient population. Data displayed in package inserts are provided to give clinicians information on the likelihood of virologic success based on pretreatment susceptibility to a given agent. Additional data are needed to determine definitive susceptibility breakpoints for a given drug. An example of this analysis is presented in Table 3.

4. Genotypic and Phenotypic Correlations: Changes in Susceptibility from Baseline

Assessing changes in susceptibility over time on treatment is an important factor in the characterization of a drug’s resistance profile. For patients who meet the protocol-specified definition of a lack or loss of virologic response, evaluation of mean and median-fold changes in susceptibility from baseline for the investigational drug and other approved drugs from both inside and outside the same class is important. In addition, analyses should be conducted on patients who develop a particular new mutation during treatment, and the median-fold change in susceptibility from baseline should be presented. Table 4 shows an example of how data from this analysis can be displayed. Efforts also should be made to define relationships between genotype and phenotype as shown in Table 5.

5. Cross-Resistance
The evaluation of cross-resistance with other drugs in the same class is important. Characterization of cross-resistance of a drug can provide health care providers and patients with information on how to choose and sequence antiretroviral drugs. Evaluation of the effect of the investigational drug on subsequent use of other drugs and how previous treatment with other drugs may affect the response to the investigational drug is essential in drug development. The former can be accomplished by designing rollover studies evaluating virologic response rates in patients discontinuing study drug in clinical trials.
We encourage sponsors to incorporate prospective rollover designs to provide for assessment of virologic responses in study patients administered subsequent antiretroviral regimens. When possible, the design of a rollover study should include a randomized control. Every effort should be made to capture as much information as possible from the original studies. Resistance testing can be used to assess the genotype and phenotype of antiretroviral-experienced patients that predict success or failure after exposure to previous therapies. This testing can involve longer follow-up of study patients, perhaps continuing into the postmarketing period.

6. Additional Analyses
In addition to the analyses previously suggested, sponsors should consider conducting the following investigations:
• Genotypic sensitivity scores (GSS) and phenotypic sensitivity scores (PSS) and virologic outcome analyses can be investigated in all phases of development. Sponsors should discuss with the division in advance methods to calculate GSS and PSS for the optimized background regimens.

• Sponsors are encouraged to conduct exposure-response analyses throughout the drug development process, beginning with phase 2a studies in HIV-infected patients. One goal of exposure-response evaluations is to aid dose selection for phase 2b and phase 3 studies. Results from exposure-response evaluations also can help determine whether dose adjustments are warranted for special populations and whether therapeutic drug monitoring may be helpful in some patients.

Exposure-response evaluations require the collection of exposure data (drug concentrations) and response data (efficacy and safety). The sponsor should discuss exposure-response evaluation plans with the division and the Office of Clinical Pharmacology before study initiation. Exposure-response evaluations should indicate which drug exposure measures (e.g., area under the curve, Ctrough) are relevant to a given virologic outcome. In addition, sponsors are encouraged to evaluate the proportion of responders to a given drug regimen by inhibitory quotient (IQ), steady-state Cmin values, and other methods, as appropriate. An IQ value is the ratio of Cmin/EC50 (protein-binding corrected).

• Pharmacogenetic analyses can be conducted to determine genetic factors that may be involved in virologic response (e.g., for co-receptor inhibitors targeting a host receptor, genetic differences in the receptor may affect response).

Source:

Drug Resistance Assay and Antiretroviral drug development guidance--->
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071173.pdf

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===========================================
FDA guidelines

good manufacturing practices
===========================================
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===========================================

There is much more information on HIV virus new findings available on this blog.

Here are given details about symptoms of AIDS , all new symptoms of AIDS and HIV virus infection are updated.

Here is the latest development on treament for HIV and AIDS

------------------------------------------------------------------------------------------------------------

This website provided complete information about hiv virus , hiv infection , early hiv symptoms , hiv treatment,hiv test and hiv testing centers, aids symptoms, symptoms of hiv immideately after infection.

------------------------------------------------------------------------------------------------------------

Following are the most read topic on this website you should find them on blog archive of this website

Stem cell treatment for AIDS

AIDS symptoms

SYMPTOMS OF HIV

HIV infection symptoms

Latest treatment for AIDS

How anti retroviral medicines are developed

How Chemotherapeutic drugs are developed to treat HIV virus infection

New drug developments against HIV Virus AIDS
Vaccines research for HIV AIDS Why it is difficult to develop a vaccine against HIV

Mother to child prevention of HIV virus infection.

hiv virus infection prevention and education bloggers

Information about HIV Virus AIDS symptoms

Last updated: 28-Oct-2010

DRUG RESISTANCE TESTING NEW DRUG DEVELOPMENT (ANTI RETROVIRAL HIV) Baseline Genotype and Virologic Response

noreply@blogger.com (Martin) — Thu, 28 Oct 2010 18:48:00 +0000

Baseline Genotype and Virologic Response
Analyses should be conducted to evaluate HIV RNA response according to the presence and absence of baseline mutations. These analyses can help assess the association between a specific mutation or mutational pattern and virologic response rates. For example, for a new nucleoside analogue, virologic response rates would be determined for patients with and without clinically relevant mutations associated with resistance to other nucleoside analogs. Table 1 shows one example of virologic response rates for a hypothetical nucleoside analog by the presence or absence of zidovudine-associated mutations at baseline.

Table 1 shows response rates according to the presence or absence of specific mutations. In clinical isolates, however, mutations often occur in patterns, some of which are considered primary and others compensatory or accessory. Exploratory analyses should be conducted to define sets of mutational patterns with the largest effect on subsequent response rates.
For some drugs, defining specific mutational patterns that best correlate with a reduction in treatment response can be difficult. In these cases, another approach can be to investigate the number of baseline mutations that affects overall response. We encourage sponsors to explore how the number of baseline mutations correlate with maximal, reduced, or minimal virologic responses. For example, the response rate (less than 400 copies/mL) in patients with 1 to 2 protease inhibitor- (PI) associated mutations at baseline may be 80 percent, 45 percent if 3 to 4 PI-associated baseline mutations are present, or 10 percent if 5 or more PI-associated baseline mutations are present. For some drugs, the number and types of mutations may be important for overall clinical response. Therefore, we recommend sponsors conduct analyses as suggested in Tables 2A and 2B. Sponsors should discuss in advance with the division the specific mutations to be included in the overall mutation score. Additional exploratory analyses may be recommended to further investigate the effect of certain mutations on virologic response.

Note the number of PI mutations (4) used in Table 2B is for illustrative purposes. The number of mutations that affect virologic response rates vary for each drug; therefore, the number and type of mutations used for analyses of HIV RNA response should be discussed with the division. We recognize the limitations of this type of analysis in that an interaction between two or more mutations may not be detected. However, this analysis may provide insight into baseline predicators of response and may provide useful information regarding relationships between number and type of mutations for further exploratory analyses.

Source:

Drug Resistance Assay and Antiretroviral drug development guidance--->
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071173.pdf

IV. NONCLINICAL STUDIES
A. Mechanism of Action
B. Antiviral Activity in Cell Culture
C. Cytotoxicity and Therapeutic Indexes
D. Protein Binding
E. Selection of Drug-Resistant HIV-1 Variants in Cell Culture
1. Genotype
2. Phenotype
F. Cross-Resistance
G. Characterization of Genotypic and Phenotypic Assays
1. Genotypic Assays
2. Phenotypic Assays
V. CLINICAL STUDIES: USE OF RESISTANCE TESTING IN CLINICAL PHASES OF DRUG DEVELOPMENT
A. General Considerations
B. Data Collection
C. Methods and Types of Analyses
1. Baseline Genotype and Virologic Response
2. Development of HIV Mutations
3. Baseline Phenotype and Virologic Response
4. Genotypic and Phenotypic Correlations: Changes in Susceptibility from Baseline
5. Cross-Resistance
6. Additional Analyses
D. Other Considerations
1. Role for Supporting Initial Activity and Dose-Finding Studies
2. Data Collection from Dose-Finding Trials
3. Use of Resistance Data to Establish an Indication
4. Use of Resistance Data for Study Enrollment Criteria, Background Regimen Selection, and Stratification Factors
5. Nonclade B Subtypes
E. Monitoring during Phase 4

REGULATORY REQUIREMENTS FOR SUBMITTING HIV RESISTANCE DATA

SUMMARY

There is much more information on HIV virus new findings available on this blog.
Here are given details about symptoms of AIDS , all new symptoms of AIDS and HIV virus infection are updated.

Here is the latest development on treament for HIV and AIDS

=================================================
Advertisements
=================================================
Good manufacturing practices

pharma process validation

=================================================
Above are advertisements
=================================================
------------------------------------------------------------------------------------------------------------
This website provideds complete information about hiv virus , hiv infection , early hiv symptoms , hiv treatment,hiv test and hiv testing centers, aids symptoms, symptoms of hiv immideately after infection.
------------------------------------------------------------------------------------------------------------

Following are the most read topic on this website you should find them on blog archive of this website
Stem cell treatment for AIDS
AIDS symptoms
SYMPTOMS OF HIV
HIV infection symptoms
Latest treatment for AIDS
How anti retroviral medicines are developed
How Chemotherapeutic drugs are developed to treat HIV virus infection
New drug developments against HIV Virus AIDS
Vaccines research for HIV AIDS Why it is difficult to develop a vaccine against HIV
Mother to child prevention of HIV virus infection.
hiv virus infection prevention and education bloggers

Information about HIV Virus AIDS symptoms

Last updated :28-Oct-2010

DRUG RESISTANCE TESTING NEW DRUG DEVELOPMENT (ANTI RETROVIRAL HIV) Methods and Types of Analyses

noreply@blogger.com (Martin) — Thu, 28 Oct 2010 18:29:00 +0000

Methods and Types of Analyses
Several types of resistance analyses can be used to characterize a drug’s resistance profile. Analyses for treatment-experienced patients are more complicated than for treatment-naïve patients. Some analyses are possible only when larger datasets are available. In phase 3, clinical trial datasets can be sufficiently large to study the effect that mutations confer upon drug susceptibility and outcome. Pooling data from several trials can be appropriate (provided the study populations, endpoints, and assays are similar), but should be discussed in advance with the division. To facilitate pooling data, sponsors should attempt to use similar, if not identical, assays during phase 3. Whenever possible, resistance analyses should be prospectively defined, with the caveat that prospectively defining key mutations or susceptibility breakpoints is not always possible. In some cases, retrospective analyses can provide important information in characterizing resistance and cross-resistance.
Because of a large number of potential comparisons, statistical testing can be problematic for analyses of resistance testing and outcome. Sponsors are encouraged to provide resistance analysis plans to the division in advance.
Analyses of virologic outcome by baseline genotype or phenotype should be based on a censored population to assess the effect of baseline resistance on outcome without confounding factors such as early discontinuation because of adverse events. Therefore, patients who discontinue study treatment while suppressed or who discontinue study treatment before confirmed suppression for adverse event, noncompliance, protocol violation, pregnancy, or withdrawal of consent should be censored. Rules for censoring patients who appear to have a virologic response before discontinuation should be discussed with the division. We encourage sponsors to analyze the baseline resistance data by the primary and secondary endpoints used in the trial. Virologic response parameters recommended for analyses include the following, but are not limited to: proportion of HIV RNA below the limit of quantification (e.g., less than 400 or less than 50 copies/mL), proportion less than 1 log10 decrease from baseline, and mean and/or median change from baseline or time average change from baseline at the protocol-specified time points. Sponsors are encouraged to discuss endpoints with the division in advance. All patients should be included in the dataset until the time of censoring. The datasets should include variables for reasons for censoring patients. Refer to Appendix A for further details.
In general, we recommend analyses of baseline genotype and phenotype for all treatment-experienced patients to evaluate baseline predictors of virologic response. In addition, genotypic and phenotypic analyses of samples obtained at baseline and at the time of virologic failure are recommended for all treatment-experienced patients to characterize resistance and cross-resistance.
The following examples reflect suggested analyses for studies in treatment-experienced patients. Sponsors are strongly encouraged to conduct additional analyses and should discuss these analyses with the division before submission of a new drug application (NDA). In most cases, we do not anticipate baseline genotype and phenotype and virologic outcome analyses, as described below, for all treatment-naïve patients. However, circumstances may arise in treatment-naïve patients where analyses of baseline resistance and virologic outcome data are warranted, particularly in the event of unexpected efficacy results. In addition, in select cases, sponsors can propose to collect samples at baseline and at the time of failure on a subset of treatment-naïve patients, for example, when cell culture data indicate that acquisition of a specific single mutation results in a high degree of phenotypic resistance.
We also acknowledge for various analyses the number of patients in certain subgroups may be limited and as a result definitive conclusions regarding specific baseline factors will not be possible.

Source:

Drug Resistance Assay and Antiretroviral drug development guidance--->
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071173.pdf

=========================================

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pharmaceutical process validation

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pharma guidelines

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Above links are advertisements
=========================================

IV. NONCLINICAL STUDIES
A. Mechanism of Action
B. Antiviral Activity in Cell Culture
C. Cytotoxicity and Therapeutic Indexes
D. Protein Binding
E. Selection of Drug-Resistant HIV-1 Variants in Cell Culture
1. Genotype
2. Phenotype
F. Cross-Resistance
G. Characterization of Genotypic and Phenotypic Assays
1. Genotypic Assays
2. Phenotypic Assays
V. CLINICAL STUDIES: USE OF RESISTANCE TESTING IN CLINICAL PHASES OF DRUG DEVELOPMENT
A. General Considerations
B. Data Collection
C. Methods and Types of Analyses
1. Baseline Genotype and Virologic Response
2. Development of HIV Mutations
3. Baseline Phenotype and Virologic Response
4. Genotypic and Phenotypic Correlations: Changes in Susceptibility from Baseline
5. Cross-Resistance
6. Additional Analyses
D. Other Considerations
1. Role for Supporting Initial Activity and Dose-Finding Studies
2. Data Collection from Dose-Finding Trials
3. Use of Resistance Data to Establish an Indication
4. Use of Resistance Data for Study Enrollment Criteria, Background Regimen Selection, and Stratification Factors
5. Nonclade B Subtypes
E. Monitoring during Phase 4

REGULATORY REQUIREMENTS FOR SUBMITTING HIV RESISTANCE DATA

SUMMARY

There is much more information on HIV virus new findings available on this blog.
Here are given details about symptoms of AIDS , all new symptoms of AIDS and HIV virus infection are updated.

Here is the latest development on treament for HIV and AIDS

------------------------------------------------------------------------------------------------------------
This website provideds complete information about hiv virus , hiv infection , early hiv symptoms , hiv treatment,hiv test and hiv testing centers, aids symptoms, symptoms of hiv immideately after infection.
------------------------------------------------------------------------------------------------------------

Following are the most read topic on this website you should find them on blog archive of this website
Stem cell treatment for AIDS
AIDS symptoms
SYMPTOMS OF HIV
HIV infection symptoms
Latest treatment for AIDS
How anti retroviral medicines are developed
How Chemotherapeutic drugs are developed to treat HIV virus infection
New drug developments against HIV Virus AIDS
Vaccines research for HIV AIDS Why it is difficult to develop a vaccine against HIV
Mother to child prevention of HIV virus infection.
hiv virus infection prevention and education bloggers

Information about HIV Virus AIDS symptoms

Last updated : 28-10-2010

DRUG RESISTANCE TESTING NEW DRUG DEVELOPMENT (ANTI RETROVIRAL HIV) USE OF RESISTANCE TESTING IN CLINICAL PHASES OF DRUG DEVELOPMENT

noreply@blogger.com (Martin) — Thu, 28 Oct 2010 18:27:00 +0000

CLINICAL STUDIES: USE OF RESISTANCE TESTING IN CLINICAL PHASES OF DRUG DEVELOPMENT
Before advances in resistance testing technologies, resistance and cross-resistance data were often obtained late in drug development or during postmarketing. However, given the current availability of resistance testing in clinical practice and the need to give health care providers information about an antiretroviral drug’s resistance profile, comprehensive resistance testing should be undertaken in all phases of drug development. Crucial decisions in protocol design and drug development hinge on resistance and cross-resistance data.
Cell culture resistance and cross-resistance studies of an investigational drug can focus the scope of drug development. For example, drugs that exhibit extensive cross-resistance with approved drugs of the same class are unlikely to be suitable for studies in treatment-experienced patients harboring resistant isolates to that class. Conversely, for drugs that demonstrate a nonoverlapping or unique resistance profile, the division strongly encourages sponsors to develop clinical protocols studying treatment-experienced individuals. Although we encourage development of new antiretroviral drugs with unique resistance profiles in treatment-experienced patients, we also encourage concurrent clinical development in antiretroviral-naïve patients as appropriate.
Epidemiological data suggest that transmission of drug-resistant HIV is on the rise, meaning one cannot assume treatment-naïve patients harbor WT virus (Little et al. 2002). In this regard, the division strongly recommends the collection and storage of samples for baseline resistance testing (preferably for both genotype and phenotype) from all HIV-infected, multiple-dose study patients, regardless of treatment history.
Methods and Types of Analyses, for further information regarding settings where analyses on baseline and follow-up samples are recommended. Knowledge of the genotype and phenotype at baseline can aid in the interpretation of unexpected antiviral responses, particularly in smaller dose-ranging studies.

A. General Considerations
The goals of resistance testing are to:
• Determine the effect of an antiviral drug on the evolution of the virus
• Identify the baseline genotypic and phenotypic determinants of virologic success or failure (or clinical success or failure) in the study

We strongly recommend resistance testing in all phases of development and, in most cases, as soon as the drug is introduced into HIV-infected patients. Data from nonclinical studies and phase 1 and phase 2 clinical trials should provide a preliminary idea of the genotypic mutations that confer reduced drug susceptibility and a lack or loss of virologic response. Phase 3 trial designs should incorporate this information and expand on it, thereby aiming to further characterize drug resistance.
In general, the type of information collected and the types of analyses conducted should be the same for all phases of development. However, the amount of data collected and the types of analyses performed may differ for treatment-naïve versus treatment-experienced patients as described below. Whenever possible, resistance analyses should be prospectively defined. However, since it is not possible to define a priori key mutations or susceptibility breakpoints, retrospective analyses can provide important information in characterizing resistance and cross-resistance. The following sections provide recommendations on the type of resistance data that should be collected during drug development and the types of analyses that should be conducted. Appendix A provides guidance for submitting HIV resistance data. Information about the specific assays and mutational algorithms used in protocols also should be provided to the division.

B. Data Collection
To characterize drug resistance during development, sponsors are strongly encouraged to collect samples from both treatment-naïve and treatment-experienced patients. Overall, the extent and type of resistance testing should be discussed and agreed upon with the division throughout drug development. Discussions with the division are particularly important for new classes of antiretroviral agents as the data and technologies are evolving. The following data should be collected and analyzed:
• Baseline phenotype and genotype samples on all study patients. Samples can be analyzed at a later date as appropriate.
The reasons for obtaining baseline samples for phenotype and genotype on all clinical trial patients are twofold. First, the prevalence and rate of transmission of drug-resistant virus is increasing (Little et al. 2002), and may continue to increase, as the HIV population becomes more treatment experienced. Second, collection of baseline data provides an opportunity to examine the relationship between genotype and phenotype and virologic response to drug, particularly in treatment-experienced patient populations. Use of resistance testing in study protocols may help in choosing appropriate combination regimens for treatment-experienced patients (see section V.C.4, Genotypic and Phenotypic Correlations: Changes in Susceptibility from Baseline, for further details).
• Post-baseline phenotype and genotype samples on all study patients, regardless of treatment history who demonstrate a lack or loss of virologic response during the trial to determine mutations that may contribute to reduced drug susceptibility.
Collecting samples for resistance testing when patients are still on study drug, or as soon as possible if study drugs are discontinued, is important. Studies have shown WT virus may outgrow resistant HIV viral strains in the absence of selective drug pressure (Devereux et al. 1999; Halfon et al. 2003). In addition, continuation of resistance monitoring on subsequent regimens can provide useful information regarding cross-resistance and sequencing of therapy. We recognize collection of resistance data on subsequent regimens is not feasible for all clinical trials or patients; however, sponsors are encouraged to consider such studies in their development plans as appropriate (see Cross-Resistance, for details) and are encouraged to discuss continuation studies with the division.

Source:

Drug Resistance Assay and Antiretroviral drug development guidance--->
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071173.pdf

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IV. NONCLINICAL STUDIES
A. Mechanism of Action
B. Antiviral Activity in Cell Culture
C. Cytotoxicity and Therapeutic Indexes
D. Protein Binding
E. Selection of Drug-Resistant HIV-1 Variants in Cell Culture
1. Genotype
2. Phenotype
F. Cross-Resistance
G. Characterization of Genotypic and Phenotypic Assays
1. Genotypic Assays
2. Phenotypic Assays
V. CLINICAL STUDIES: USE OF RESISTANCE TESTING IN CLINICAL PHASES OF DRUG DEVELOPMENT
A. General Considerations
B. Data Collection
C. Methods and Types of Analyses
1. Baseline Genotype and Virologic Response
2. Development of HIV Mutations
3. Baseline Phenotype and Virologic Response
4. Genotypic and Phenotypic Correlations: Changes in Susceptibility from Baseline
5. Cross-Resistance
6. Additional Analyses
D. Other Considerations
1. Role for Supporting Initial Activity and Dose-Finding Studies
2. Data Collection from Dose-Finding Trials
3. Use of Resistance Data to Establish an Indication
4. Use of Resistance Data for Study Enrollment Criteria, Background Regimen Selection, and Stratification Factors
5. Nonclade B Subtypes
E. Monitoring during Phase 4

REGULATORY REQUIREMENTS FOR SUBMITTING HIV RESISTANCE DATA

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