Pitt-Ohio State Clinical Trials Unit

项目摘要 皮特-俄亥俄州立临床试验单位(PIT-OSU CTU)及其位于 宾夕法尼亚州匹兹堡的匹兹堡大学(Pitt CRS)和哥伦布的俄亥俄州立大学(OSU CRS)， 俄亥俄州，是一个高绩效的CTU，对DAIDS网络的科学和管理领导都至关重要 用于艾滋病毒治疗和艾滋病毒预防。皮特-俄亥俄州立大学CTU提议继续与 艾滋病临床试验小组(ACTG)和艾滋病毒预防试验网络(HPTN)。此外，皮特-俄亥俄州 CTU准备在科学能力和接触受影响和处于危险中的人方面进一步扩大 参与艾滋病毒疫苗试验网络(HVTN)的人口。因此，皮特-俄亥俄州立大学CTU将做出贡献 几个DAIDS HIV/AIDS临床试验网络的研究议程，从而实现预期的 CTU的效率。这项申请的目的是：1)继续推进科学议程 通过开发和实施高优先级研究，建立艾滋病艾滋病毒/艾滋病治疗和预防网络 作为关键的协议团队成员进行研究，在主要的网络领导和科学委员会任职，以及 通过指导ACTG实验室中心(LC)病毒学和免疫学专业实验室；2)招募， 招募、留住和监测DAIDS网络高优先级方案的研究参与者，并会见和 超越这些网络建立的性能标准；3)与我们社区中的合作伙伴接触， 包括俄亥俄州哥伦布市，位于富兰克林县(美国艾滋病毒最高的48个县之一 负担)支持执行符合国家“结束艾滋病毒流行”的科学倡议 计划“；4)与受影响的社区和社区咨询委员会合作 努力；以及5)指导每个CRS确定的年轻调查人员成为熟练的、独立的 研究人员。艾滋病毒治疗的主要科学领域将包括艾滋病毒蓄水池和艾滋病毒控制。 在没有抗逆转录病毒治疗的情况下复制(“非抗逆转录病毒疗法缓解”)；治疗的新的长效干预措施 艾滋病毒；预防和治疗艾滋病毒相关的非传染性并存和乙肝 为了预防，PIT-OSU CTU将利用过去十年发展起来的技能和专业知识，专注于长期的 暴露前预防(PrEP)用有效抗逆转录病毒制剂和给药系统.评价 预防艾滋病毒的多用途预防技术和广谱中和抗体；以及 预防艾滋病毒的综合战略。集体专业知识、管理效率和绩效 PIT-OSU CTU及其CRSS在上一个赠款周期的记录确保这些具体目标是可以实现的 皮特-俄亥俄州立大学CTU将为DAIDS赞助的研究议程做出重要贡献 网络，最终目标是结束艾滋病的流行。

Project Summary The Pitt-Ohio State Clinical Trials Unit (Pitt-OSU CTU), and its two Clinical Research Sites (CRSs) at the University of Pittsburgh (Pitt CRS) in Pittsburgh, PA, and The Ohio State University (OSU CRS) in Columbus, Ohio, is a high performing CTU that is vital for both scientific and administrative leadership in the DAIDS networks for HIV Therapeutics and HIV Prevention. The Pitt-OSU CTU proposes to continue its productive affiliations with the AIDS Clinical Trials Group (ACTG) and the HIV Prevention Trials Network (HPTN). Additionally, the Pitt-OSU CTU is poised to expand further in terms of scientific capabilities and access to both affected and at risk populations to participate in the HIV Vaccine Trials Network (HVTN). As such, the Pitt-OSU 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 continue to advance the scientific agenda of the DAIDS HIV/AIDS Therapeutic and Prevention networks by developing and implementing high-priority research studies as key protocol team members, by serving on major network leadership and scientific committees, and by directing the ACTG Laboratory Center (LC) Virology and Immunology Specialty Laboratories; 2) to recruit, enroll, retain and monitor study participants in high-priority protocols of the DAIDS networks, and to meet and exceed performance standards established by these networks; 3) to engage with partners in our communities, including Columbus, Ohio, located in Franklin County (one of the 48 counties in the US with the highest HIV burden) to support implementation science initiatives consistent with the national “Ending the HIV Epidemic Plan”; 4) to partner with affected communities and community advisory boards at each CRS throughout these endeavors; and 5) to mentor young investigators identified at each CRS to become skilled, independent researchers. The key scientific areas of focus in HIV therapeutics will include HIV reservoirs and control of HIV replication in the absence of ART (“ART-free remission”); novel and long-acting interventions for the treatment of HIV; and prevention and treatment of HIV-related non-infectious co-morbidities and Hepatitis B. In HIV Prevention, the Pitt-OSU CTU will utilize skills and expertise developed over the past decade to focus on long- acting antiretroviral agents and delivery systems for Pre-exposure Prophylaxis (PrEP); evaluation of multipurpose prevention technologies (MPTs) and broadly neutralizing antibodies for HIV prevention; and integrated strategies for HIV prevention. The collective expertise, administrative efficiency, and performance record of the Pitt-OSU CTU and its CRSs over the last grant cycle ensure that these Specific Aims are achievable and that the Pitt-OSU CTU will make important contributions to the research agendas of DAIDS-sponsored networks, with the ultimate goal of ending the AIDS epidemic.