PACTG 1025: PERINATAL CORE PROTOCOL

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。这项前瞻性队列研究将招募大约2400对母婴（每月40对，5年）。当达到特定样本量时，登记将不会停止，但将继续进行，直到围产期传播RAC和儿科执行委员会决定停止登记（基于应计和事件发生率的定期审查）。研究对象为妊娠14周或分娩过活产或死产婴儿并在分娩后7天内感染艾滋病毒的孕妇。妇女将被跟踪到产后24个月，婴儿6-12个月。这项研究的主要目标是：1)评估预防艾滋病毒垂直传播和/或妇女健康规定的干预措施（例如抗逆转录病毒治疗和分娩方式）的有效性；2)评估为妇女健康和/或预防艾滋病毒垂直传播而规定的干预措施（例如抗逆转录病毒治疗和分娩方式）的母婴安全性；3)为子研究（如P1026s，妊娠期药代动力学）、New Works Concepts Sheets （NWCS）和Data Analysis Concept Sheets （DACS）提供框架和样本库，旨在进一步阐明HIV垂直传播的危险因素和机制以及影响母婴结局的因素；4)评估感染艾滋病毒（艾滋病）的孕妇在怀孕和产后坚持抗逆转录病毒治疗及其对妇女健康和垂直传播的影响，并评估婴儿坚持化学预防的情况。

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.