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资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。这项前瞻性队列研究将入组约2400对母婴（每月40对x5年）。当达到特定样本量时，不会停止入组，但将继续入组，直到围产期传播RAC和儿科执行委员会决定停止入组（基于对累积和事件发生率的定期审查）。受试者人群为妊娠≥ 14周或分娩活产或死产婴儿且在分娩后7天内的HIV感染女性。将对妇女进行随访至产后24个月，对婴儿进行随访至6-12个月。本研究的主要目标是：1）评估干预措施的有效性（例如，2）评估干预措施的母婴安全性（例如，为妇女健康和/或预防艾滋病毒垂直传播而开的处方（包括抗逆转录病毒疗法和分娩方式）; 3）为子研究提供框架和样本库（如P1026，妊娠期药代动力学），新工厂概念表（NWCS），数据分析概念表（DACS）旨在进一步阐明艾滋病毒垂直传播的风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）的孕妇在怀孕期间和产后坚持抗逆转录病毒治疗的情况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。