Coordinating Center for the Pediatric HIV/AIDS Cohort S*

儿科艾滋病毒/艾滋病队列 S 协调中心*

• 批准号: 7032020
• 负责人: RUSSELL B. VAN DYKE
• 金额: $ 81.65万
• 依托单位: TULANE UNIVERSITY OF LOUISIANA
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-30 至 2010-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7032020
• 关键词: AIDS; HIV infections; biomedical facility; clinical research; cooperative study; growth /development; longitudinal human study; mitochondrial disease /disorder; pediatrics

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.

描述（由申请人提供）：PHACS 协调中心 (CC) 由 PI、项目主任和一组主要研究人员组成，其中包括科学领导小组 (SLG)。 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。 EC 将是 PHACS 的主要管理机构，将为所有团体活动提供监督和最终批准。 CC 将负责 PHACS 的整体管理。 SLG 将负责确定 PHACS 的科学议程，并在第一年制定两项解决该议程的方案，每项方案都有自己的一组受试者、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。这将是一个持续累积的开放协议；最初受试者将从 WITS 和 PACTG 219c 研究中招募。它将产生一群未感染艾滋病毒的儿童，这些儿童将受到纵向监测，了解线粒体疾病、生长发育异常以及其他终末器官疾病的发展情况。基本方案将解决艾滋病毒感染对性成熟、青春期发育和围产期艾滋病毒感染的青春期前儿童和青少年社会化的影响，并确定青春期围产期艾滋病毒感染的过程。这将是一个封闭队列，由之前参加过 WITS 和 219c 的 7-16 岁受试者组成。基本协议将与 CDC 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有针对性的子研究，以解决各种具体的科学问题。对于基本协议队列，这些包括： 神经发育和学术/职业成果；生长、发育、身体成分和新陈代谢的变化；线粒体疾病和 ART 引起的其他毒性；高脂血症、其他心脏危险因素和心血管并发症；生殖和妇科结果以及 HPV 感染；以及艾滋病毒感染的传染性和非传染性并发​​症。