PItt-Ohio State-Georgetown Clinical Trials Unit

描述(由申请人提供)：OSUPITTGU临床试验单位(CTU)由宾夕法尼亚州匹兹堡的匹兹堡大学(PITT CRS)、俄亥俄州哥伦布市的俄亥俄州立大学(OSU CRS)和华盛顿特区的乔治敦大学(GU CRS)的3个临床研究站点(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)建立富有成效的联系，在这两个网络进行的广泛研究中发挥科学和行政领导作用，并对参与者进行登记和跟踪。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)研究的议定书特定地点参加，并有能力在科学能力和接触受影响人群和高危人群方面进一步扩大。因此，OSUPITTGU CTU将为几个艾滋病、艾滋病毒/艾滋病临床试验网络的研究议程作出贡献，从而实现CTU所期望的效率。这项申请的目的是：1)通过开发和实施重点关注艾滋病毒储存和病毒根除(艾滋病毒治愈)、肝炎和终末器官疾病和炎症的高优先级研究，推进ACTG的科学议程；2)通过开发和实施关于含有抗逆转录病毒的阴道环、直肠杀菌剂和联合方法的安全性和有效性的高优先级研究，推进MTN的科学议程；3)迅速将CTU的现有能力扩展到艾滋病毒和抗菌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)在宾夕法尼亚州西部、俄亥俄州中部、阿巴拉契亚北部和华盛顿特区，为受艾滋病毒/艾滋病疫情影响最大的难以接触到的贫困人口提供获得DAIDS赞助的试验的机会，这些地区没有其他途径获得治疗试验；5)招募、招募、留住和监督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绩效标准；6)在所有这些努力中与每个CRS的受影响社区和社区顾问委员会合作；以及7)在每个CRS指导承诺成为熟练研究人员的年轻研究人员。OSUPITTGU CTU在上一个赠款周期的集体专门知识、行政效率和业绩记录确保了这些目标是可以实现的，并确保CTU将对DAIDS和DMID网络的研究议程作出重要贡献。 相关性：皮特-俄亥俄州立大学-乔治敦大学临床试验单位是一项合作努力，将支持DAIDS艾滋病毒/艾滋病研究网络，特别注重艾滋病毒治疗和预防方面的关键研究领域，包括艾滋病毒治愈、非传染性合并症、丙型肝炎和结核病；艾滋病毒预防战略，包括暴露前预防和杀菌剂；以及DMID赞助的抗菌素耐药性细菌临床试验。

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.