PItt-Ohio State-Georgetown Clinical Trials Unit

描述（申请人提供）：OSUPITTGU临床试验部门（CTU）由匹兹堡大学的3个临床研究中心（CRS）组成（PITT CRS），位于宾夕法尼亚州匹兹堡的俄亥俄州州立大学（OSU CRS），位于俄亥俄州哥伦布市，乔治敦大学（GU CRS），位于华盛顿，建议继续与艾滋病临床试验组（ACTG）和杀微生物剂试验网络（MTN）建立富有成效的联系，为科学和行政领导做出贡献，以及两个网络开展的广泛研究的参与者的登记和随访。此外，OSUPITTGU CTU准备继续参与艾滋病毒预防试验网络（HPTN）和艾滋病毒疫苗试验网络（HVTN）的研究方案特定网站，并有能力进一步扩大科学能力和接触受影响和风险人群的能力。因此，OSUPPITTGU CTU将为几个DAIDS艾滋病毒/艾滋病临床试验网络的研究议程做出贡献，从而实现CTU所需的效率。该申请的目的是：1）通过开发和实施重点关注艾滋病毒储存库和病毒根除的高优先级研究，推进ACTG的科学议程（HIV治愈）、肝炎、终末器官疾病和炎症; 2）通过制定和实施关于抗逆转录病毒药物的安全性和有效性的高度优先研究，推进MTN的科学议程，3）迅速扩大CTU现有的能力，进入艾滋病毒和抗生素耐药性研究的新领域，以满足DAIDS和DMID赞助的网络不断变化的需求; 4）为巴勒斯坦权力机构西部受艾滋病毒/艾滋病流行影响最严重的难以接触和贫困人口提供获得艾滋病防治司赞助的试验的机会，俄亥俄州中部、北方阿巴拉契亚和华盛顿，DC，在这些地区没有其他途径进行治疗试验; 5）招募、招募、保留和监测ACTG、MTN、HPTN和HVTN高优先级方案的研究参与者，并达到或超过这些网络的性能标准; 6）在这些努力中与受影响的社区和每个CRS的社区咨询委员会合作; 7）指导每个CRS有前途的年轻研究人员成为熟练的研究人员。OSUPITTGU CTU在上一个资助周期的集体专业知识、行政效率和绩效记录确保了这些目标的实现，CTU将为DAIDS和DMID网络的研究议程做出重要贡献。

DESCRIPTION (provided by applicant): The OSUPITTGU Clinical Trials Unit (CTU), composed of 3 Clinical Research Sites (CRSs) at the University of Pittsburgh (PITT CRS) in Pittsburgh, PA, Ohio State University (OSU CRS) in Columbus, Ohio, and Georgetown University (GU CRS) in Washington, DC, proposes to continue its productive affiliations with the AIDS Clinical Trials Group (ACTG) and the Microbicide Trials Network (MTN), contributing scientific and administrative leadership, as well as enrollment and follow-up of participants in a broad range of studies conducted by both Networks. Additionally, the OSUPITTGU CTU is poised to continue its participation as protocol specific sites for studies in the HIV Prevention Trials Network (HPTN) and the HIV Vaccine Trials Network (HVTN), and has capacity to expand further in terms of scientific capabilities and access to both affected and at risk populations. As such, the OSUPITTGU CTU will contribute to the research agendas of several DAIDS HIV/AIDS Clinical Trials Networks and thereby achieve the desired efficiency for a CTU. The Aims of this application are: 1) to advance the scientific agenda of the ACTG through development and implementation of high-priority research studies focused on HIV Reservoirs and Viral Eradication (HIV Cure), Hepatitis, and End-organ Disease and Inflammation; 2) to advance the scientific agenda of the MTN through development and implementation of high-priority research studies on the safety and efficacy of antiretroviral-containing vaginal rings, rectal microbicides, and combination approaches; 3) to rapidly expand existing CTU capacity into new areas of HIV and antimicrobial resistance research to meet the evolving needs of DAIDS- and DMID-sponsored Networks; 4) to provide access to DAIDS-sponsored trials for hard-to-reach and impoverished populations most impacted by the HIV/AIDS epidemic in western PA, central OH, northern Appalachia, and Washington, DC, where no other access to therapeutic trials exists; 5) to recruit, enroll, retain and monitor study participants in high-priority protocols of the ACTG, MTN, HPTN, and HVTN, and meet or exceed performance standards for these Networks; 6) to partner with affected communities and community advisory boards at each CRS throughout these endeavors; and 7) to mentor promising young investigators at each CRS to become skilled researchers. The collective expertise, administrative efficiency, and performance record of the OSUPITTGU CTU over the last grant cycle ensure that these Aims are achievable and that the CTU will make important contributions to the research agendas of DAIDS and DMID Networks.