PACTG 1025: 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. This prospective cohort study will enroll approximately 2400 mother-infant pairs (40 pairs per month x 5 years). Enrollment will not be stopped when a specific sample size is reached, but will continue until the Perinatal Transmission RAC and Pediatric Executive Committee decide to discontinue enrollment (based on periodic reviews of accrual and event rates). The subject population is HIV-infected women who are pregnant and >=14 weeks gestation or who have delivered a liveborn or stillborn infant and are within 7 days of delivery of their infants. Women will be followed to 24 months postpartum and infants 6-12 months of age. The primary objectives of this study are: 1) to assess the effectiveness of interventions (e.g., antiretroviral therapy and mode of delivery) prescribed for prevention of vertical transmission of HIV and/or for women's health; 2) To assess maternal and infant safety of interventions (e.g., antiretroviral therapy and mode of delivery) prescribed for women's health and/or for prevention of vertical transmission of HIV; 3) To provide a framework and specimen repository for substudies (such as P1026s, pharmacokinetics in pregnancy), New Works Concepts Sheets (NWCS), and Data Analysis Concept Sheets (DACS) that aim to further elucidate risk factors for and mechanisms of vertical transmission of HIV and factors that affect maternal and infant outcomes; 4) To assess adherence to antiretroviral therapy among HIV-infected (AIDS-infected) pregnant women during pregnancy and postpartum and its impact on women's health and vertical transmission, and to assess adherence to chemoprophylaxis in infants.