PACTG P1025: PERINATAL CORE PROTOCOL

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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. PACTG P1025 is a prospective cohort study with the primary goal of enrolling pregnant, HIV-infected women receiving prenatal care at PACTG sites and their infants into a study in which clinical and laboratory (virologic, immunologic, and biochemical) data and specimens for repository storage are obtained according to a standardized protocol. It is anticipated that complementary, well-designed substudies will be developed as adjuncts to the standardized core protocol. The primary hypotheses that this study will investigate are: * Antiretroviral therapy resulting in viral loads under 1000cp/ml will be effective in reducing the risk of HIV transmission to below 1%. * Women with greater adherence to treatment will have lower viral loads. * Adherence to treatment will be greater during pregnancy than during the months following delivery. PACTG P1025 is designed to enroll a large representative sample of pregnant HIV-infected women who receive care at PACTG and collaborating sites. Women will be followed until 12 months postpartum. Infants will be followed for 6-12 months in P1025 and subsequently roll-over into PACTG 219C, a long-term observation study for HIV-exposed infants and children. Medical records will be abstracted to obtain data concerning medical history, physical examination, and laboratory studies conducted as part of clinical care. Specifically, supplemental data concerning ART use, adherence to medications, and review of symptoms relevant to side effects and toxicities will be collected through administration of questionnaires. At study visits, phlebotomy will be conducted in order to obtain specimens for a repository and to obtain specimens for required laboratory tests. At labor and delivery, attempts to collect information on placental pathology and to collect amniotic fluid for storage will be made.