PACTG P1025: PERINATAL CORE PROTOCOL

PACTG P1025：围产期核心方案

• 批准号: 7605074
• 负责人: Elizabeth Jane McFarland
• 金额: $ 19.18万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-03-01 至 2008-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7605074
• 关键词: Adherence; Adverse effects; Amniotic Fluid; Biochemical; Caring; Child; Clinical; Cohort Studies; Computer Retrieval of Information on Scientific Projects Database; Data; Enrollment; Funding; Goals; Grant; HIV; Immunologics; Infant; Institution; Laboratories; Laboratory Study; Medical History; Medical Records; Pathology; Patient currently pregnant; Perinatal; Pharmaceutical Preparations; Physical Examination; Postpartum Period; Pregnancy; Prenatal care; Protocols documentation; Questionnaires; Research; Research Personnel; Resources; Risk; Sampling; Site; Source; Specimen; Symptoms; Testing; Toxic effect; United States National Institutes of Health; Venous blood sampling; Viral Load result; Visit; Woman; abstracting; antiretroviral therapy; design; prospective; repository; transmission process

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. PACTG P1025 is a prospective cohort study with the primary goal of enrolling pregnant, HIV-infected women receiving prenatal care at PACTG sites and their infants into a study in which clinical and laboratory (virologic, immunologic, and biochemical) data and specimens for repository storage are obtained according to a standardized protocol. It is anticipated that complementary, well-designed substudies will be developed as adjuncts to the standardized core protocol. The primary hypotheses that this study will investigate are: * Antiretroviral therapy resulting in viral loads under 1000cp/ml will be effective in reducing the risk of HIV transmission to below 1%. * Women with greater adherence to treatment will have lower viral loads. * Adherence to treatment will be greater during pregnancy than during the months following delivery. PACTG P1025 is designed to enroll a large representative sample of pregnant HIV-infected women who receive care at PACTG and collaborating sites. Women will be followed until 12 months postpartum. Infants will be followed for 6-12 months in P1025 and subsequently roll-over into PACTG 219C, a long-term observation study for HIV-exposed infants and children. Medical records will be abstracted to obtain data concerning medical history, physical examination, and laboratory studies conducted as part of clinical care. Specifically, supplemental data concerning ART use, adherence to medications, and review of symptoms relevant to side effects and toxicities will be collected through administration of questionnaires. At study visits, phlebotomy will be conducted in order to obtain specimens for a repository and to obtain specimens for required laboratory tests. At labor and delivery, attempts to collect information on placental pathology and to collect amniotic fluid for storage will be made.

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。 PACTG P1025是一项前瞻性队列研究，主要目标是将在PACTG地点接受产前护理的怀孕、艾滋病毒感染妇女及其婴儿纳入一项研究，该研究根据标准化方案获得临床和实验室(病毒学、免疫学和生化)数据和样本以进行储存库存储。预计将制定补充的、设计良好的次级研究，作为标准化核心议定书的附件。这项研究将调查的主要假设是： *病毒载量低于1000cp/ml的抗逆转录病毒疗法将有效地将艾滋病毒传播的风险降低到1%以下。 *坚持治疗的妇女将拥有较低的病毒载量。 *怀孕期间对治疗的坚持程度将高于分娩后的几个月。 PACTG P1025旨在招募在PACTG和合作地点接受护理的具有代表性的怀孕艾滋病毒感染妇女的大样本。女性将被跟踪到产后12个月。在P1025中，婴儿将被跟踪6-12个月，然后进入PACTG 219C，这是一项针对感染艾滋病毒的婴儿和儿童的长期观察研究。作为临床护理的一部分，医疗记录将被提取以获取有关病史、体检和实验室研究的数据。具体地说，将通过管理问卷收集有关ART使用、药物依从性以及与副作用和毒性相关的症状审查的补充数据。在考察访问时，将进行静脉采血，以便为储存库获取样本，并为所需的实验室测试获得样本。在分娩和分娩时，将尝试收集关于胎盘病理的信息，并收集羊水进行储存。