PItt-Ohio State-Georgetown Clinical Trials Unit

描述（由申请人提供）：OSUPITTGU临床试验小组（CTU）由宾夕法尼亚州匹兹堡大学（PITT CRS）、俄亥俄州哥伦布市俄亥俄州立大学（OSU CRS）和华盛顿特区乔治城大学（GU CRS）的3个临床研究中心（CRS）组成，建议继续与艾滋病临床试验小组（ACTG）和杀微生物剂试验网络（MTN）建立有效的联系，贡献科学和行政领导。以及两个网络进行的广泛研究的参与者的登记和随访。此外，OSUPITTGU CTU准备继续作为艾滋病毒预防试验网络（HPTN）和艾滋病毒疫苗试验网络（HVTN）研究的协议特定地点参与，并有能力在科学能力和接触受影响和危险人群方面进一步扩大。因此，OSUPITTGU

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. RELEVANCE: The Pitt-Ohio State-Georgetown Clinical Trials Unit is a collaborative effort that will support the DAIDS HIV/AIDS research networks with a particular focus on critical areas of research in HIV therapy and prevention including: HIV cure, non-infectious comorbidities, hepatitis C, and tuberculosis; HIV prevention strategies including pre-exposure prophylaxis and microbicides; and DMID-sponsored clinical trials for antimicrobial resistant bacteria.