PACTG 1025: PERINATAL CORE PROTOCOL (AIDS)

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The efficacy of antiretroviral therapy in preventing vertical transmission of HIV is undisputed. The investigators note, however, that a small percentage of children born to HIV-infected mothers are infected. Doing a controlled study in this population is unethical. Thus the PACTG will follow approximately 2400 mother/infant pairs who will be treated at PACTG sites and determine which children become infected, to which drug regimens their mothers were prescribed, how difficult it was to follow the regimen and how closely they adhered to it. They will compare efficacy of interventions prescribed, safety of interventions prescribed and adherence to antiretroviral therapy by HIV-infected pregnant women and its impact on vertical transmission. They will also establish a repository for specimens for future studies to evaluate risk factors and outcomes. They hypothesize that adherence will be better during pregnancy than post-partum; more complex regimens will have poorer adherence; toxicity will give poorer adherence. This study will help evaluate issues in treating pregnant women with HIV. Many are already enrolled in treatment studies. Uniformity of data collection and determination of fetal outcomes will provide much needed information regarding best treatment during pregnancy. Enrollment has begun and is continuing on this multicenter trial.