PACTG P1025: PERINATAL CORE PROTOCOL

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。PACTG P1025是一项前瞻性队列研究，其主要目标是将在PACTG站点接受产前护理的孕妇、艾滋病毒感染妇女及其婴儿纳入一项研究，该研究根据标准化协议获得临床和实验室（病毒学、免疫学和生化）数据和用于存储库的标本。预期将制定补充性的、设计良好的次级研究，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的病毒载量低于1000cp/ml将有效地将艾滋病毒传播的风险降低到1%以下。*坚持治疗的妇女病毒载量较低。*怀孕期间比分娩后几个月更能坚持治疗。PACTG P1025旨在招募在PACTG和合作站点接受治疗的艾滋病毒感染孕妇的大量代表性样本。这些女性将被跟踪到产后12个月。婴儿将在P1025中随访6-12个月，随后转入PACTG 219C，这是一项针对艾滋病毒暴露婴儿和儿童的长期观察研究。将提取医疗记录，以获得有关病史、体格检查和作为临床护理一部分的实验室研究的数据。具体而言，将通过问卷调查收集有关抗逆转录病毒治疗使用、药物依从性以及与副作用和毒性有关的症状审查的补充数据。在研究访问时，将进行静脉切开术，以便为储存库获取标本，并为必要的实验室测试获取标本。在分娩和分娩时，将尝试收集胎盘病理信息并收集羊水进行储存。

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.