Coordinating Center for the Pediatric HIV/AIDS Cohort S*

描述（由申请人提供）：PHACS的协调中心（CC）由PI、项目主任和由科学领导小组（SLG）组成的一组主要研究人员组成。CC将与数据运营中心一起建立PHACS的领导结构，包括执行委员会（EC）、外部监督委员会和SLG。欧共体将是PHACS的主要管理机构，并将对所有集团活动进行监督和最终批准。中心将负责PHACS的全面管理。SLG将负责确定PHACS的科学议程，并在第1年期间制定解决这一议程的两个方案，每个方案都有自己的受试者队列、具体目标和子研究。药物毒性监测系统将评估对子宫内和新生儿期暴露于艾滋病毒的婴儿进行预防性抗逆转录病毒治疗的安全性。这将是一项持续累积的开放协议；最初将从WITS和PACTG 219c研究中招募受试者。它将产生一批未感染艾滋病毒的儿童，他们将被纵向监测线粒体疾病、生长发育异常和其他终末器官疾病的发展。基本议定书将处理艾滋病毒感染对围产期感染艾滋病毒的前青少年和青少年的性成熟、青春期发育和社会化的影响，并确定青少年围产期感染艾滋病毒的过程。这将是一个封闭的队列，包括7-16岁的受试者，他们之前参加过WITS和219c。基础方案将与疾病预防控制中心遗产项目充分协调，以扩大可用于研究罕见事件的人群。一旦在第一年制定了协议，SLG将利用一个或两个队列开发各种重点子研究，以解决各种具体的科学问题。对于基础方案队列，这些包括：神经发育和学术/职业结果；生长、发育、身体组成和新陈代谢的变化；由抗逆转录病毒治疗引起的线粒体疾病和其他毒性；高脂血症、其他心脏危险因素和心血管并发症；生殖和妇科结果与HPV感染；以及艾滋病毒感染的传染性和非传染性并发症。

DESCRIPTION (provided by applicant): The Coordinating Center (CC) of the PHACS consists of the PI, project director, and a group of leading investigators comprising the Scientific Leadership Group (SLG). Together with the Data Operations Center, the CC will establish the leadership structure of the PHACS including an Executive Committee (EC), an External Oversight Committee, and the SLG. The EC will be the main governing body of the PHACS and will provide oversight and final approval for all group activities. The CC will be responsible for overall management of the PHACS. The SLG will be responsible for defining the scientific agenda of the PHACS and, during year 1, the development of the two protocols which will address this agenda, each with its own cohort of subjects, specific objectives, and sub-studies. The Drug Toxicity Surveillance System will evaluate the safety of preventive antiretroviral therapy when administered to HIV-exposed infants in utero and in the newborn period. This will be an open protocol with ongoing accrual; initially subjects will be enrolled from the WITS and PACTG 219c studies. It will generate a cohort of HIV-uninfected children who will be monitored longitudinally for the development of mitochondrial disease, abnormalities in growth and development, and other end-organ disease. The Base Protocol will address the impact of HIV-infection on sexual maturation, pubertal development, and socialization of perinatally HIV-infected preadolescents and adolescents and define the course of perinatal HIV infection during adolescence. It will be a closed cohort, consisting of subjects 7-16 years of age who were previously enrolled in WITS and 219c. The Base Protocol will be fully coordinated with the CDC Legacy Project in order to expand the population available to study uncommon events. Once the protocols are developed in year one, a variety of focused sub-studies, utilizing one or both of the cohorts, will be developed by the SLG in order to address a variety of specific scientific questions. For the Base Protocol cohort, these include: neurodevelopmental and academic/vocational outcomes; changes in growth, development, body composition, and metabolism; mitochondrial disease and other toxicities resulting from ART; hyperlipidemias, other cardiac risk factors, and cardiovascular complications; reproductive and gynecologic outcomes and HPV infections; and infectious and non-infectious complications of HIV infection.