Institute of Human Virology Clinical Trials Unit

描述（由申请人提供）： 人类病毒学临床试验研究所（IHV-CTU）整合了五个临床研究中心（CRS），四个在美国（巴尔的摩-华盛顿联盟），一个在西非的尼日利亚，专注于四个主要研究目标：药物研究和开发;成人，青少年和儿科人群的临床管理优化;艾滋病毒预防;疫苗研究和开发。IHVCTU领导，PI，William A. Blattner，MD，Co-Pi Robert R. Redfield MD和Co-Pi John F.法利医学博士指导特定的研究领域，并在IHV-CTU沟通计划指导下的协作过程中阐明互补优势，以实施最高GCP标准的试验。IHV治疗CRS，[研究中心负责人（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帕特里克McLeroth，医学博士）采用社区临床基地进行临床管理研究试验的优化，惠特曼步行者CRS也是如此，其SL是Philippe Chiliade，医学博士。项目BRAVE CRS，（SL威廉A。布拉特纳医学博士）在巴尔的摩社区有着深厚的根基，目标是艾滋病毒疫苗的研究和开发。IHV尼日利亚 CRS，SL John F.法利医学博士，利用一个实质性的10,000多PEPFAR（总统艾滋病紧急救援计划）治疗队列，进行艾滋病毒预防试验中的艾滋病毒不和谐的夫妇在艾滋病毒CRF_02 AG感染的风险。IHV-CTU通过组织结构和沟通计划协调研究实践，该计划在所有CRS中采用统一的标准操作程序（SOP），并优化研究实践的临床管理工作组。由PI和Co-Pi组成的执行委员会分配和重新分配资源，以适应由研究者委员会指导的新兴临床试验优先事项，通过重新分配CTU资源来推进最有希望的干预措施。CRS通过社区活动咨询委员会（CAB）的社区参与通过IHV-CTU CAB联系起来，以实现社区教育和招募，有效地吸引服务不足的非洲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共卫生。 行政部门：

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: