Interested candidates should submit their curriculum vitae or a pertinent biographical sketch and a letter of nomination or letter of interest outlining the experience and qualifications relevant to this position and the contributions the candidate is likely to bring to the Panel. Please submit nominations electronically (via e-mail) by March 24, 2008, to Lynne Mofenson, M.D., Executive Secretary, National Institute of Child Health and Human Development, National Institutes of Health, 6100 Executive Blvd., Room 4B11, Rockville, MD 20852, Fax: 301-496-8678; e-mail: LM65D@nih.gov or Lynne.Mofenson@nih.hhs.gov

The Pediatric Working Group, a Working Group of the Office of AIDS Research Advisory Council (OARAC) of the National Institutes of Health (NIH), is composed of approximately 25 members who are clinicians, researchers, academicians, and HHS representatives with expertise in pediatric HIV management, as well as community representatives with knowledge of HIV infection in children. The Working Group meets monthly via teleconferencing and on occasion in a face-to-face meeting to review and critically evaluate emerging scientific data relating to antiretroviral therapy in infants and children. The members actively engage in the preparation and update of the “Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection,” which appears as a living document on the http://AIDSinfo.nih.gov Web site. This document is widely used by HIV practitioners and researchers in the United States.

Working Group members are not compensated for their time commitment and travel support is not provided for participation.

The Working Group is currently seeking nominations for new members with expertise in pediatric HIV clinical trials, outcome research, and/or clinical practice who will work with other Panel members in critically evaluating new information and preparing revisions to the Pediatric Antiretroviral Guidelines. The candidates should have scientific expertise in pediatric/adolescent HIV infection as evidenced by meaningful contributions to peer-reviewed journals related to pediatric HIV infection, participation in pediatric clinical research networks, receipt of NIH funding related to pediatric HIV infection as principal or co-principal investigator and/or clinical expertise in pediatric HIV infection as evidenced by more than 5 years experience in the field of HIV and ongoing participation in the clinical care of HIV-infected children/adolescents, and recognition of clinical expertise by peers (such as certification by HIV Medical Association/Infectious Disease Society of America, membership on HIV-related committees of the American Academy of Pediatrics, and consultant to Centers for Disease Control and Prevention or World Health Organization on pediatric HIV-related issues). Because these are guidelines focused on pediatric antiretroviral management for the United States, candidates must be from the United States. Candidates should be willing to dedicate the necessary time to participate on the Working Group–a minimum of monthly conference calls and willingness to actively write revisions. The successful candidates shall serve a 3-year term starting in April 2008.

The nomination should include a curriculum vitae and a letter of nomination or letter of interest outlining what qualities and contributions the candidate may bring to the Panel. Please submit nominations electronically (via e-mail) no later than March 24, 2008, to Lynne M. Mofenson, M.D., Executive Secretary, National Institute of Child Health and Human Development, National Institutes of Health, 6100 Executive Blvd., Room 4B11, Rockville, MD 20852, Fax: 301-496-8678; e-mail: LM65D@nih.gov or Lynne.Mofenson@nih.hhs.gov

Gay-rights activists are joining AIDS advocates in lobbying Congress to end travel restrictions on HIV-positive visitors to the United States. The limits are discriminatory since HIV is the only medical condition the Immigration and Nationality Act (INA) makes grounds for prohibiting a non-national’s entry, critics say.

Under a 1993 amendment to INA, HIV-positive visitors may obtain visas to enter the United States, but only under limited circumstances and if they receive a waiver from the Department of Homeland Security (DHS).

Under a provision in the Senate bill that reauthorizes the President’s Emergency Plan for AIDS Relief, the 1993 restrictions would be deleted. The Senate Foreign Relations Committee could vote on the measure on Thursday. The House PEPFAR bill does not contain language repealing the restrictions. A stand-alone measure to strike the travel limits is also being sponsored by Rep. Barbara Lee (D-Calif.) and Sen. John Kerry (D-Mass.).

Ending the exclusionary policy is a “reform that is long needed,” Kerry said in a conference call with Lee and Joe Solmonese of the Human Rights Campaign. The International AIDS Conference has not been held in the United States since Congress passed the restriction, Lee noted. The United States is one of a small number of countries that block the entrance of HIV-positive foreigners, according to rights activists.

Under a rule proposed by DHS, foreign HIV-positive travelers would have to gain US entry approval from American consulates in their home countries. Critics contend the law is not an improvement, as it still requires travelers to agree to certain conditions such as those that would preclude staying longer or applying for permanent residency.

Data were analyzed from 41,213 HIV-infected patients who were followed for an average of 4 years between 1993 and 2003. Almost all of the patients were men; 52% were black, and 83% were aged 35 to 55. During the observation period, the all-cause mortality rate fell from 20.9 to 5.2 deaths per 100 patient-years. The steepest decline occurred after potent ART first became available, but death rates continued to decrease throughout the next 8 years. The relative hazard for serious cardiovascular disease (defined as inpatient stay for myocardial infarction or the equivalent) was not increased with 2, 3, or 4 years of PI- or NNRTI-based ART, compared with no ART exposure. The authors conclude that ART confers an increasingly powerful survival benefit while posing only a negligible public health risk from cardiovascular effects.

Comment: This report does not provide data about the rates of known cardiovascular risk factors (e.g., smoking, hypertension, and diabetes) or about specific antiretrovirals in this population. The definition used for cardiovascular events would miss premorbid events, such as angina or severe metabolic disturbances, that would be managed initially in the outpatient setting. Curiously, the rate of serious cardiovascular events was lower for blacks than for whites in this study, which is not the case in the general U.S. population. The reassuring results from this updated analysis of the VA study are at odds with much of the published literature in the field, so their applicability to other populations of HIV-infected patients remains unclear.

— Keith Henry, MD
Published in AIDS Clinical Care March 3, 2008
Citation(s):
Bozzette SA et al. Long-term survival and serious cardiovascular events in HIV-infected patients treated with highly active antiretroviral therapy. J Acquir Immune Defic Syndr 2007 Dec 20; [e-pub ahead of print].

Previous studies have shown that people tend to reduce their high-risk sexual behavior when they learn that they are HIV infected (ACC Sep 14 2005). According to the CDC, the proportion of HIV-infected people who are aware of their serostatus has increased in recent years — from 70.5% in 2001 to 74.2% in 2004. Could this increase in awareness be at least partially responsible for the fact that HIV incidence held steady during the same time period, despite an increase in HIV prevalence?

To address this question, researchers devised a mathematical model of the U.S. HIV epidemic from 2001 through 2004 and calculated the number of incident infections that would have occurred had the level of serostatus awareness remained unchanged. The model — built with CDC epidemiologic data — showed that approximately 6000 new HIV infections (range, 4000–8700) were prevented during the study period.

Comment: That HIV incidence has remained steady at 40,000 new cases per year for at least a decade is a major disappointment and reflects the need for enhanced prevention efforts. Although the authors clearly share this perspective, they have also managed to cast this statistic in a more positive light, by focusing on the fact that HIV incidence has not increased in recent years, even though prevalence has. Their data indicate that HIV testing and counseling efforts are at least partially responsible for preventing a rise in new cases in the U.S. Although other prevention efforts may have also contributed to this trend, HIV testing clearly played an important role and should remain a high priority in the U.S.

— Salim S. Abdool Karim, MD, PhD
Published in AIDS Clinical Care March 3, 2008
Citation(s):
Pinkerton SD et al. Infections prevented by increasing HIV serostatus awareness in the United States, 2001 to 2004. J Acquir Immune Defic Syndr 2007 Dec 20; [e-pub ahead of print].

Infant and maternal mortality figures are rising in South Africa as the HIV/AIDS epidemic continues, according to the Department of Health report “Every Death Counts” released Tuesday. HIV/AIDS is responsible for 35 percent of all infant and child deaths in South Africa, a finding that a source working on the report said the health minister tried but failed to excise.

South Africa “is one of only 12 countries globally that has seen a reversal in infant mortality rates since the goals were set in 1990, and that is obviously due to HIV,” said Joy Lawn, co-author of the report and a senior policy and research advisor for Save the Children.

Several countries with similar gross national incomes and mortality rates to South Africa’s are on track to reduce child deaths by two-thirds and maternal deaths by three-quarters by 2015, yet no progress has been made by South Africa, the report said.

Every year in South Africa, 20,000 babies are stillborn, 22,000 die within four weeks of birth, and at least 75,000 children die before age five. At least 1,600 women die due to the complications of childbirth.

About 40,000 deaths could be averted annually if the country stepped up implementation of existing policies and programs to improve infant and maternal health, Lawn said. Expectant mothers, for instance, have to fight barriers to specialized obstetric care, including having a caesarian section. The lack of essential equipment at government health care centers should also be addressed, she said.

Health Minister Manto Tshabalala-Msimang demanded that researchers remove the section tying infant and child deaths to HIV/AIDS, according to leaked documents confirmed by someone close to the project. The report’s authors seem to have reached a compromise by including the information as an addendum.

In a letter released on Wednesday, the Food and Drug Administration and Johnson & Johnson warned of reported liver damage and death in patients taking the company’s HIV drug Prezista. According to the drug maker, the cases of drug-induced hepatitis as well as liver injury and death have not been linked directly to Prezista, a once-daily protease inhibitor taken in combination with ritonavir. Fifteen cases of liver problems were reported during clinical trials, said Pam Van Houten of Tibotec Therapeutics, a unit of Johnson & Johnson. The company did not provide information on post-marketing cases reported after Prezista’s US approval in 2006, she noted. Most of the cases occurred in patients with advanced HIV who were taking multiple medications, and in those who were co-infected with hepatitis B or C, the letter said. For more information, visit http://www.fda.gov/medwatch/safety/2008/safety08.htm#Prezista.

On Tuesday, the International Partnership for Microbicides (IPM) announced it has received permission to use Merck and Co.’s experimental HIV drug L’644 in testing as a potential vaginal microbicide. L’644 is a gp41 inhibitor that would block HIV from attaching to immune cells.

“It’s a completely different mechanism of action to what we have currently under development and what the field has under development,” said Dr. Zeda Rosenberg, IPM’s CEO. “It’s pretty early in the life cycle for HIV. Most of us feel that, for a microbicide to be really effective, it has to get at the infection in its earliest time points.”

While condoms can protect men and women, in many countries a woman who insists on condom use can face rejection or violence. In contrast, a woman could take it upon herself to use a microbicide gel or cream to prevent HIV infection. In sub-Saharan Africa, about 61 percent of adults with HIV are women, according to UNAIDS.

“L’644 is a peptide that would need to be injected to act as an effective antiviral,” said Dr. Daria Hazuda, vice president of scientific affairs for infectious disease at Merck Research Laboratories. “As such, it was not deemed to have a favorable profile for patient convenience.” Merck, therefore, is not developing L’644 as a drug to treat HIV.

IPM has agreements with other drug firms to develop microbicides, said Rosenberg. Other microbicide candidates include Merck’s L’167/CMPD167 compound, a CCR5 blocker; Pfizer’s CCR5 inhibitor maraviroc; Gilead Sciences’ tenofovir, in collaboration with Bristol-Myers Squibb; and Johnson & Johnson’s Tibotec Pharmaceutical’s dapivirine.

On Thursday, the Senate Foreign Relations Committee voted 18-3 in favor of a $50 billion, five-year extension of the President’s Emergency Plan for AIDS Relief (PEPFAR). The vote comes two weeks after the House Foreign Affairs Committee endorsed a similar measure.

The Senate bill, S 2731, would more than triple the $15 billion initially allotted for PEPFAR five years ago. The program targets 15 countries in Africa, the Caribbean, and Asia. Under PEPFAR, some 1.4 million people have received antiretroviral treatment and more than 6.6 million have received HIV/AIDS-related support. “Over 2 million orphans and vulnerable children have received care, education, and support,” said committee chair Sen. Joseph Biden (D), who introduced the bill with top-ranking Sen. Richard Lugar (R) and two other members. “Across Africa, we have given millions of people hope for a better and longer life.”

The Senate version includes a measure introduced by Sen. John Kerry (D) that lifts a ban on HIV-positive people entering the United States. While people with the disease have the option of requesting a waiver, “the process is incredibly restrictive,” said Kerry.

Similar to the House bill, S 2731 would ease requirements in the 2003 act that one-third of all prevention money be spent on abstinence-based programs, instead directing the administration to promote “balanced funding for prevention activities.”

Family planning is not mentioned in S 2731. The House, in response to concerns that AIDS money might be used for abortions, included a provision that allows the use of funds for HIV/AIDS testing and counseling services by US-supported family planning programs.

The Chinese Ministry of Construction in 2007 launched a program whose goal is to teach immigrant workers how to avoid HIV/AIDS. Since then, 30,667 laborers have taken the two-hour course.

In October, a supervisor at a large job site in Changsha, capital of Hunan province, asked his workers to take the course. One who did so was Chen Wei, a 27-year-old who had worked at more than 20 construction sites across China. “I was previously told by others that AIDS was more disastrous than cancer. But I didn’t relate it with us Chinese,” Chen said.

Zhou Yiran, the instructor, informed Chen and his classmates that HIV/AIDS is indeed present in the underdeveloped province, which has documented 4,974 cases. A more accurate figure, however, would likely be five to six times higher. Furthermore, the participants heard that the disease is making greater inroads into the general population.

Changsha is home to an estimated 20,000 recreational venues, including massage parlors, karaoke bars and beauty salons, spots where construction workers far from their families can access prostitutes. “My friends are not used to using condoms, simply because they are very uncomfortable,” Chen said.

Class participants are also told that HIV can pass from a mother to her baby, but that it cannot be transmitted by mosquitoes.

Nine trainers presented 87 such lectures to more than 5,000 workers in the Changsha region in just two weeks. And they reported that the scores on a nine-question quiz increased from less than 60 percent before the instruction to 83.8 percent afterward.