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。 PACTG P1025是一项前瞻性队列研究，主要目的是招募在PACTG研究中心接受产前护理的HIV感染孕妇及其婴儿参加研究，根据标准化方案获得临床和实验室（病毒学、免疫学和生物化学）数据以及储存库储存的标本。 预计将开发补充的、设计良好的子研究，作为标准化核心方案的补充。 本研究将调查的主要假设是： * 抗逆转录病毒治疗导致病毒载量低于1000 cp/ml将有效降低艾滋病毒传播的风险至1%以下。 * 坚持治疗的妇女病毒载量较低。 * 妊娠期间对治疗的依从性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HIV感染孕妇的大型代表性样本。女性将被随访至产后12个月。 婴儿将在P1025中随访6-12个月，随后转入PACTG 219 C，这是一项针对HIV暴露婴儿和儿童的长期观察研究。 将提取病历，以获得作为临床护理一部分进行的病史、体格检查和实验室研究相关数据。 具体而言，将通过问卷调查收集关于ART使用、药物依从性以及副作用和毒性相关症状审查的补充数据。 在研究访视时，将进行放血术，以获取标本用于储存库，并获取标本用于所需的实验室检查。 在分娩和分娩时，将尝试收集胎盘病理学信息并收集羊水储存。