PACTG 1025: PERINATAL CORE PROTOCOL (AIDS)

PACTG 1025：围产期核心方案（艾滋病）

• 批准号: 7605703
• 负责人: William Borkowsky
• 金额: $ 24.58万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-04-01 至 2008-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7605703
• 关键词: Acquired Immunodeficiency Syndrome; Adherence; Child; Complex; Computer Retrieval of Information on Scientific Projects Database; Controlled Study; Data Collection; Enrollment; Funding; Future; Grant; HIV; Infant; Institution; Intervention; Mothers; Multicenter Trials; Outcome; Perinatal; Pharmaceutical Preparations; Population; Pregnancy; Pregnant Women; Protocols documentation; Research; Research Personnel; Resources; Risk Factors; Safety; Site; Source; Specimen; Toxic effect; Treatment Efficacy; Treatment Protocols; United States National Institutes of Health; Vertical Disease Transmission; antiretroviral therapy; fetal; prevent; repository

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. The efficacy of antiretroviral therapy in preventing vertical transmission of HIV is undisputed. The investigators note, however, that a small percentage of children born to HIV-infected mothers are infected. Doing a controlled study in this population is unethical. Thus the PACTG will follow approximately 2400 mother/infant pairs who will be treated at PACTG sites and determine which children become infected, to which drug regimens their mothers were prescribed, how difficult it was to follow the regimen and how closely they adhered to it. They will compare efficacy of interventions prescribed, safety of interventions prescribed and adherence to antiretroviral therapy by HIV-infected pregnant women and its impact on vertical transmission. They will also establish a repository for specimens for future studies to evaluate risk factors and outcomes. They hypothesize that adherence will be better during pregnancy than post-partum; more complex regimens will have poorer adherence; toxicity will give poorer adherence. This study will help evaluate issues in treating pregnant women with HIV. Many are already enrolled in treatment studies. Uniformity of data collection and determination of fetal outcomes will provide much needed information regarding best treatment during pregnancy. Enrollment has begun and is continuing on this multicenter trial.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 抗逆转录病毒疗法在预防艾滋病毒垂直传播方面的功效是无可争议的。 然而，调查人员注意到，感染艾滋病毒的母亲所生的孩子中有一小部分被感染。 在这个人群中进行对照研究是不道德的。 因此，PACTG将跟踪大约2400对将在PACTG站点接受治疗的母亲/婴儿，并确定哪些儿童受到感染，他们的母亲接受了哪些药物治疗方案，遵循该方案的难度以及他们坚持该方案的程度。他们将比较所规定的干预措施的有效性，艾滋病毒感染孕妇接受抗逆转录病毒治疗的安全性及其对垂直传播的影响。 他们还将建立一个标本库，供未来研究评估风险因素和结果。 他们假设妊娠期间的依从性优于产后;更复杂的方案依从性较差;毒性依从性较差。 这项研究将有助于评估治疗感染艾滋病毒的孕妇的问题。 许多人已经参加了治疗研究。 数据收集的统一性和胎儿结局的确定将提供关于妊娠期间最佳治疗的急需信息。 该多中心试验的入组工作已经开始并正在继续。