CLINICAL TRIAL: PACTG 1025: PERINATAL CORE PROTOCOL (AIDS)

临床试验：PACTG 1025：围产期核心方案（艾滋病）

• 批准号: 7718399
• 负责人: William Borkowsky
• 金额: $ 20.7万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-04-01 至 2009-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7718399
• 关键词: Acquired Immunodeficiency Syndrome; Adherence; Child; Clinical Trials; 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利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 抗逆转录病毒疗法在预防艾滋病毒垂直传播方面的有效性是毋庸置疑的。然而，调查人员指出，感染艾滋病毒的母亲所生的孩子中有一小部分被感染。在这一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地点接受治疗的母婴，并确定哪些儿童受到感染，给他们的母亲开了哪些药物方案，遵循方案的难度有多大，以及他们遵守方案的程度。他们将比较规定的干预措施的有效性、规定的干预措施的安全性、艾滋病毒感染孕妇坚持抗逆转录病毒治疗及其对垂直传播的影响。他们还将建立一个标本储存库，用于未来的研究，以评估风险因素和结果。他们假设，妊娠期间的依从性比产后更好；更复杂的方案依从性更差；毒性将使依从性更差。这项研究将有助于评估孕妇感染艾滋病毒的治疗问题。许多人已经参加了治疗研究。统一的数据收集和胎儿结局的确定将提供孕期最佳治疗方面亟需的信息。这项多中心试验的登记工作已经开始，并仍在继续。