Pitt-Ohio State Clinical Trials Unit

项目摘要 匹兹堡-俄亥俄州立大学临床试验单位（Pitt-OSU CTU）及其位于美国加利福尼亚州的两个临床研究中心（CRS） 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州立大学（OSU CRS）， 俄亥俄州是一个高性能的CTU，对于DAIDS网络的科学和行政领导至关重要 艾滋病治疗和预防。皮特-俄勒冈州立大学CTU建议继续与 艾滋病临床试验组（ACTG）和艾滋病预防试验网络（HPTN）。此外，Pitt-OSU 反恐组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 艾滋病毒疫苗试验网络（HVTN）。因此，皮特-俄勒冈州立大学反恐组将 艾滋病毒/艾滋病临床试验网络的研究议程，从而实现预期的 反恐小组的效率这项申请的目的是：1）继续推进联合国的科学议程， DAIDS艾滋病毒/艾滋病治疗和预防网络，开展和实施高度优先研究 研究作为关键协议团队成员，通过服务于主要网络领导和科学委员会， 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， 在DAIDS网络的高优先级协议中招募、保留和监测研究参与者，并满足和 超越这些网络建立的绩效标准; 3）与我们社区的合作伙伴合作， 包括俄亥俄州的哥伦布，位于富兰克林县（美国艾滋病毒感染率最高的48个县之一 负担），以支持实施符合国家"结束艾滋病毒流行"战略的科学举措， 计划"; 4）在这些期间与受影响的社区和社区咨询委员会在每个CRS合作 努力; 5）指导每个CRS确定的年轻研究人员成为熟练的，独立的 研究人员艾滋病毒治疗的重点科学领域将包括艾滋病毒储存库和艾滋病毒的控制 在没有ART的情况下复制（"无ART缓解"）;用于治疗的新型长效干预措施 预防和治疗与艾滋病毒有关的非传染性并发症和B型肝炎。艾滋病毒 预防，皮特-俄勒冈州立大学反恐组将利用过去十年发展的技能和专门知识， 暴露前预防（PrEP）的作用抗逆转录病毒药物和输送系统; 用于预防艾滋病毒的多用途预防技术和广泛中和抗体;以及 预防艾滋病毒的综合战略。集体专长、行政效率和绩效 皮特-俄勒冈州立大学CTU及其CRS在上一个拨款周期的记录确保了这些特定目标的实现 皮特-俄勒冈州立大学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.