The NHLBI has a longstanding commitment to research on issues related to women's health in general. The NIH policy for including women and minorities in study populations is strictly adhered to; thus, women are represented in all AIDS clinical research studies, as well as in other areas. In addition to this general policy, which applies to all AIDS clinical grants, the NHLBI supports programs that specifically address the issues of AIDS in women. The NHLBI AIDS Ad Hoc Working Group, the NHLBI's advisory group on AIDS research, is charged with proposing AIDS research initiatives that address women's health issues. One program developed by that group is accruing patients into a full-scale trial: it is a study on hyper-immune globulin (HIVIG) in infected pregnant women. This and other relevant programs are discussed below.
Although this study, which started in fiscal year 1989, is designed primarily to look at the prevalence and natural history of the pulmonary and cardiac complications of HIV infection in utero, infancy, and early childhood, the factors involved in maternal-fetal transmission of the virus and the relationship of different variables to disease progression in pregnant woman are also being investigated. It is expected that 400 HIV-1-antibody-positive pregnant women will be enrolled. These women are being monitored during the course of their pregnancy by serology and culture for Epstein-Barr virus, cytomegalovirus, and HIV-1, as well as T cell subsets (CD3, CD4+, CD8). Thorough medical histories are being taken and counseling is made available. Specialists in obstetrics, gynecology, pediatric pulmonology and cardiology are being encouraged to recruit women and babies who otherwise might not have access to clinical trials and the health benefits that participation can confer.
This program is studying the efficacy of HIV-immune globulin in preventing transmission of HIV-1 from the mother to the fetus. Data on the clinical effects on the mother during and after her pregnancy are being collected. Efforts are being made to use and develop effective recruitment and retention procedures for this group of patients who are often harder to recruit for clinical trials and difficult to retain, once enlisted. The trial will continue through 1996.
This study started in fiscal year 1983. It is examined factors important in the sexual transmission of HIV-1 from men to women in a group of HIV-1-infected hemophiliacs. Immune markers of infected women are being observed to determine their relationship to progression of disease and to determine the natural history of heterosexually transmitted HIV infection in women without other risk factors. Approximately 1,675 women, ages 1 to 91, were enrolled in the study, of whom about 22 percent are black and 10.2 percent are Hispanic.