NIAID supports clinical trials networks through the NIAID Division of AIDS to identify effective therapies for men, women and children with HIV infection.
The Adult AIDS Clinical Trials Group (ACTG) is a network of 30 sites based at major academic institutions with the ability to carry out sophisticated large-scale research studies.
The Pediatric AIDS Clinical Trials Group (PACTG) is a network of 21 sites funded by NIAID and 25 NICHD-funded sites, all based at major academic institutions across the United States. PACTG investigators conduct studies addressing the safety and toxicity of antiretroviral drugs and immunotherapy used during pregnancy, as well as larger trials aimed at reducing perinatal HIV transmission. The PACTG also supports a follow-up study for HIV-infected women who were enrolled in ACTG 076.
The Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA) complements the ACTG by building on the expertise of primary care providers, involving them in the design and conduct of scientifically sound, community-based clinical trials.
In addition, through the NIAID Division of Intramural Research, the Institute conducts basic and clinical research toward the development of treatments and vaccines for men, women and children with HIV infection.
The NIAID-supported HIVNET, established in 1993, conducts large-scale trials in the United States and abroad to evaluate the efficacy of vaccines and other strategies to prevent transmission of HIV.
NIAID's clinical trials programs are committed to ensuring the inclusion of HIV-infected women, conducting research on conditions that affect both non-pregnant and pregnant women, and identifying real or potential barriers that prevent the recruitment and retention of women into research studies. Funds are available to clinical trials sites for ancillary services to do gynecologic assessments and to help provide child care, transportation and linkage to social services when needed.
The Women's Health Committee of the Adult ACTG provides advice and ensures that the network's scientific agenda reflects women's issues. As part of their mandate, the committee reviews the eligibility requirements for ACTG studies to determine whether certain criteria, such as weight or blood iron, contribute to the difficulties in enrolling women in studies.
The Patient Care Committee of the Adult ACTG has evaluated other possible barriers that may prevent women from participating in clinical trials. They found many women with HIV lack access to health care, HIV-related information, and have few options to support themselves and their children. The Women, Children and People of Color Interest Group of the CPCRA also has explored this issue. Researchers in both networks work closely with Community Constituency Groups (CCGs), church groups, social workers and others at the grassroots level to find solutions to these problems.
In addition, the Adult ACTG has established two working groups, the HPV Working Group and the Wasting Pathogen Study Group, which have made women-specific research issues priorities of their scientific agendas.
Community involvement is an important part of the clinical trials networks. The CPCRA and the Adult and Pediatric ACTGs each receive advice from members of HIV-affected communities through CCGs. In the case of the Pediatric and Adult ACTGs, CCG members are selected from Community Advisory Boards (CABs) that provide direction to, and oversight of, clinical trials at the local level. CCG members serve as full and active members on all committees of the ACTG and CPCRA to ensure community input into NIAID's scientific agenda.
Increased Representation of Women in Clinical Trials. The ACTG and CPCRA have included women in their trials since the networks were established. The overall enrollment of women in NIAID trials has climbed steadily and now approaches the rate of female U.S. AIDS cases. As of April 1997, women accounted for 19 percent of the adults in the CPCRA, and 15 percent of those in the ACTG. In 1996, women accounted for 20 percent of adult U.S. AIDS cases.
NIAID supports large cohort studies that are providing important information on HIV and AIDS in women.
The Women's Interagency HIV Study (WIHS), a multicenter, prospective cohort study, was established in August 1993 to explore the natural history of HIV infection in U.S. women. WIHS researchers are comprehensively investigating the impact of HIV among women aged 13 and older, who are seen at clinic sites every six months. Primary research areas that are currently being studied or developed in the WIHS, with the help of the WIHS Community Advisory Board, include:
The spectrum of HIV-related conditions in women.
Aspects of HIV infection that are specific to women, such as genital infections and conditions (e.g., HPV infection) that lead to cervical cancer.
HIV disease progression and related viral, immunologic and hormonal factors.
Substance abuse and sexual behavior, and their relationship to risk reduction interventions and healthcare utilization.
Treatment compliance and its role in disease episodes.
WIHS accrual was completed in October 1995 at six U.S. sites, with 2,080 HIV-infected women and 575 HIV-uninfected women at risk for HIV infection. To enroll women representative of the national HIV/AIDS epidemic, including "hard-to-reach" women such as injection drug users, study investigators have used multifaceted strategies such as providing childcare, food vouchers and transportation; soliciting community advice in designing protocols; and employing culturally competent and bilingual staff. Recent data from the WIHS provide important information on the risk factors for HIV infection in women.
The WIHS is co-sponsored by NIAID and other NIH institutes: National Institute of Child Health and Human Development, National Institute on Drug Abuse, National Cancer Institute, and National Institute of Dental Research.
The WIHS is collaborating with a companion multicenter, prospective cohort study of HIV in women, The HIV Epidemiology Research Study (HERS), which is sponsored by the CDC and NIAID. HERS has enrolled 920 HIV-infected and 460 HIV-uninfected women in four U.S. sites. The HERS clinical sites are funded in part by NIAID.
A large amount of information has been collected on HIV-infected individuals since September 1990 through the NIAID-supported Observational Database (ODB), a component of the CPCRA. The CPCRA researchers are attempting to characterize the full spectrum of HIV infection and to provide an epidemiologic profile of the infection in both men and women. Information is collected on transmission, symptoms, current treatments and factors associated with disease progression. Because participating women receive care from community physicians, the ODB also offers a snapshot of routine clinical practice. Women enrolled in the ODB who meet eligibility requirements have the opportunity to participate in CPCRA treatment protocols.
Other NIAID initiatives include the Heterosexual AIDS Transmission Study (HATS), a collaborative project with the CDC, which began in December 1988 and ended in 1994. A subsequent study is tracking the acquisition of STDs in women with HIV infection and following the natural course of their HIV disease. This study, called the Women's AIDS Cohort Study (WACS), has enrolled 450 HIV-infected and high-risk uninfected women. NIAID merged WACS with WIHS in June 1994.
WACS investigators have found that women diagnosed with HIV reduce their number of sex partners, increase condom use and show a trend towards stopping use of illegal drugs.
Questions regarding women who have HIV and are pregnant include the effects of anti-HIV drugs on both the mother and the fetus, the influence of HIV on pregnancy and the effects of pregnancy on the course of HIV infection. Current NIAID studies such as the Women and Infants Transmission Study (WITS) will answer many of these questions. NIAID established WITS in 1988 in collaboration with NICHD. The study addresses specific questions relating to the natural history of HIV in pregnant and non-pregnant women, including gynecologic complications, changes in the immune system and progression of disease. WITS emphasizes the long-term follow-up of HIV-infected women after they have given birth. The study has successfully recruited a population of more than 1,500 women enrollees from diverse racial/ethnic backgrounds who are representative of the HIV epidemic among women in the United States.
For More Information About Treatment and Clinical Trials
NIAID provides major support for the AIDS Clinical Trials Information Service, at 1-800-TRIALS-A, to advise callers of the status of HIV clinical trials being conducted throughout the United States. The AIDS Treatment Information Service at 1-800-HIV-0440 provides information about federally approved treatment guidelines. Both services operate from 9 a.m. to 7 p.m. Eastern Time, Monday through Friday. English- and Spanish-speaking specialists are available.
The NIAID HIV/AIDS Research Agenda and fact sheets on NIAID HIV/AIDS vaccine research, clinical trials for AIDS therapies and vaccines, and on AIDS-related opportunistic infections are available from the NIAID Office of Communications. To receive free copies, call (301) 496-5717, Monday through Friday, 8:30 a.m. to 5:00 p.m. Eastern Time.
NIAID, a component of the National Institutes of Health, supports research on AIDS, tuberculosis and other infectious diseases as well as allergies and immunology.
Office of Communications National Institute of Allergy and Infectious Diseases National Institutes of Health Bethesda, MD 20892
Public Health Service U.S. Department of Health and Human Services April 1997