Institute of Human Virology Clinical Trials Unit

描述(由申请人提供)：人体病毒学临床试验研究所(IHV-CTU)整合了五个临床研究网站(CRS)，四个在美国(一个巴尔的摩-华盛顿财团)，一个在西非尼日利亚，专注于四个主要研究目标：药物研发；优化成人、青少年和儿童人口的临床管理；艾滋病毒预防；疫苗研发。IHVCTU领导层，Pi，William A.Blattner，MD，Co-PI Robert R.Redfield MD和Co-PI John F.Farley MD在IHV-CTU沟通计划指导下的协作过程中指导特定研究领域并阐明互补优势，以实施最高GCP标准的试验。IHV治疗CRS[Site Leader(SL)Charles Davis MD]拥有4000人的诊所基地，目标是药物开发和临床管理优化。Chase Brexton CRS(SL Patrick McLeroth，MD)雇用社区临床基地进行临床管理研究试验的优化，其SL为Philippe Chiliade，MD的Whitman Walker CRS也是如此。勇敢CRS项目(SL William A.Blattner MD)在巴尔的摩社区有着深厚的根基，以艾滋病毒疫苗研发为目标。尼日利亚IHV CRS，SL John F.Farley医学博士，利用10,000多个PEPFAR(总统艾滋病紧急救济计划)治疗队列，在有艾滋病毒CRF_02 AG感染风险的艾滋病毒不和谐夫妇中进行艾滋病毒预防试验。IHV-CTU通过组织结构和在所有CRS中采用统一标准操作程序(SOP)的沟通计划以及优化研究实践的临床管理工作组来协调研究实践。由PI和Co-PI组成的执行委员会分配和重新分配资源，以适应在调查委员会的指导下出现的临床试验优先事项，通过重新分配CTU资源来推进最有希望的干预措施。CRS通过社区积极咨询委员会(CAB)参与社区活动，通过IHV-CTU CAB联系起来，实现社区教育和招募，有效地让服务不足的非裔美国人参与试验研究。这项临床研究的结果通过提高艾滋病毒治疗标准、开发疫苗和学习更有效的艾滋病毒预防方法来影响公众健康。 管理组件：

DESCRIPTION (provided by applicant): The Institute of Human Virology Clinical Trials Unit (IHV-CTU) integrates five clinical research sites (CRS) four in the US (a Baltimore-Washington consortium) and one in Nigeria, West Africa that focus on four major research objectives: Drug Research and Development; Optimization of Clinical Management for adult, adolescent and pediatric populations; HIV Prevention; and Vaccine Research and Development. The IHVCTU leadership, PI, William A. Blattner, MD, Co-Pi Robert R. Redfield MD and Co-Pi John F. Farley MD direct specific research areas and articulate complementary strengths in a collaborative process guided by the IHV-CTU communication plan to implement trials of highest GCP standard. The IHV-Treatment CRS, [Site Leader (SL) Charles Davis MD], with a 4000 person clinic base, targets Drug development and Optimization of Clinical Management. The Chase Brexton CRS (SL Patrick McLeroth, MD) employs a community clinical base to undertake Optimization of Clinical Management research trials, as does the Whitman Walker CRS, whose SL is Philippe Chiliade, MD. The Project BRAVE CRS, (SL William A. Blattner MD) with deep roots in the Baltimore community, targets HIV vaccine research and development. The IHV Nigeria CRS, SL John F. Farley MD, exploits a substantial 10,000 plus PEPFAR (President's Emergency Program for AIDS Relief) treatment cohort, to undertake HIV prevention trials among HIV discordant couples at risk for HIV CRF_02 AG infection. The IHV-CTU harmonizes research practice through organizational structures and a communication plan that employs uniform standard operating procedures (SOP) across all CRS, and clinical management working groups that optimize research practice. An Executive Committee comprised of the PI and Co-Pi allocate and reallocate resources to adapt to emerging clinical trial priorities guided by the Investigators Committee that advance the most promising interventions by re-allocating CTU resources. CRS community engagement through community-active advisory boards (CAB) are linked through the IHV-CTU CAB to effect community education and recruitment that effectively engages underserved African American populations in trials research. Results of this clinical research impact the public health by advancing HIV treatment standards, developing a vaccine, and learning more effective approaches to HIV prevention. ADMINISTRATIVE COMPONENT: