PACTG 1025: PERINATAL CORE PROTOCOL

PACTG 1025：围产期核心方案

• 批准号: 7376265
• 负责人: RUSSELL B. VAN DYKE
• 金额: $ 1.37万
• 依托单位: TULANE UNIVERSITY OF LOUISIANA
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7376265
• 关键词: PACTG; 1025; PERINATAL; CORE; PROTOCOL

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.

该子项目是利用 NIH/NCRR 资助的中心拨款提供的资源的众多研究子项目之一。子项目和研究者 (PI) 可能已从另一个 NIH 来源获得主要资金，因此可以在其他 CRISP 条目中出现。列出的机构是中心的机构，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，为期 5 年）。当达到特定样本量时，不会停止登记，但会继续进行，直到围产期传播 RAC 和儿科执行委员会决定停止登记（根据应计率和事件率的定期审查）。受试者人群是怀孕且妊娠≥14周或已产下活产或死产婴儿且在产后7天内的HIV感染妇女。女性将被跟踪至产后 24 个月，婴儿将被跟踪至 6-12 个月。本研究的主要目标是： 1) 评估为预防艾滋病毒垂直传播和/或妇女健康而规定的干预措施（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采取的干预措施（例如抗逆转录病毒治疗和分娩方式）的孕产妇和婴儿安全性； 3) 为子研究（如P1026、妊娠药代动力学）、新工作概念表（NWCS）和数据分析概念表（DACS）提供框架和样本库，旨在进一步阐明垂直传播的危险因素和机制艾滋病毒和影响孕产妇和婴儿结局的因素； 4) 评估感染艾滋病毒（AIDS）的孕妇在怀孕期间和产后抗逆转录病毒治疗的依从性及其对妇女健康和垂直传播的影响，并评估婴儿化学预防的依从性。