Pitt-Ohio State Clinical Trials Unit

俄亥俄州匹兹堡临床试验中心

• 批准号: 10306347
• 负责人: SUSAN L KOLETAR
• 金额: $ 235.56万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-02-01 至 2027-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10306347
• 关键词: AIDS clinical trial group; AIDS prevention; AIDS/HIV problem; Acquired Immunodeficiency Syndrome; Administrative Efficiency; Affect; Anti-Retroviral Agents; Appalachian Region; Area; Arts; Clinical Trials; Clinical Trials Network; Clinical Trials Unit; Communities; County; Disease remission; Enrollment; Ensure; Epidemic; Evaluation; Goals; Grant; HIV; HIV Vaccine Trials Network; HIV prevention trials network; HIV therapy; HIV vaccine; Hepatitis B; Immunology; Individual; Intervention; Laboratories; Leadership; Mentors; Modality; Monitor; Ohio; Participant; Pennsylvania; Performance; Population; Populations at Risk; Poverty; Prevention; Prevention strategy; Protocols documentation; Records; Research; Research Personnel; Research Priority; Scientific Advances and Accomplishments; System; Technology; Therapeutic; Universities; West Virginia; clinical research site; comorbidity; follow-up; implementation science; medical specialties; member; neutralizing antibody; neutralizing vaccine; novel; pre-exposure prophylaxis; recruit; research study; skills; virology

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.

项目概要 匹兹堡-俄亥俄州立大学临床试验中心 (Pitt-OSU CTU) 及其两个临床研究中心 (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立大学 (OSU CRS)， 俄亥俄州是一个高性能的 CTU，对于 DAIDS 网络中的科学和行政领导至关重要 皮特-俄勒冈州立大学 CTU 提议继续与艾滋病毒治疗和艾滋病毒预防组织保持富有成效的联系。 艾滋病临床试验组 (ACTG) 和艾滋病毒预防试验网络 (HPTN)。 CTU 准备进一步扩大科学能力以及接触受影响和面临风险的人员 人口参与艾滋病毒疫苗试验网络 (HVTN) 因此，皮特-俄勒冈州立大学 CTU 将做出贡献。 纳入多个 DAIDS HIV/AIDS 临床试验网络的研究议程，从而实现预期目标 CTU 的效率 该应用程序的目标是： 1) 继续推进 CTU 的科学议程。 DAIDS 通过开发和实施高度优先的研究来建立艾滋病毒/艾滋病治疗和预防网络 通过在主要网络领导层和科学委员会中任职，作为关键协议团队成员进行研究，以及 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 超越这些网络制定的绩效标准；3) 与我们社区的合作伙伴合作， 包括俄亥俄州哥伦布市富兰克林县（美国艾滋病毒感染率最高的 48 个县之一） 负担）支持与国家“结束艾滋病流行”一致实施的科学举措 4) 在整个过程中与每个 CRS 的受影响社区和社区咨询委员会合作 努力；5) 指导每个 CRS 确定的年轻研究人员变得熟练、独立 研究人员重点关注的艾滋病毒治疗科学领域包括艾滋病毒储存库和艾滋病毒控制。 在没有 ART 的情况下复制（“无 ART 缓解”）； 艾滋病毒；以及艾滋病毒相关非传染性合并症和乙型肝炎的预防和治疗。 预防方面，皮特-俄勒冈州立大学 CTU 将利用过去十年开发的技能和专业知识，重点关注长期 用于暴露前预防（PrEP）评估的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（MPT）和广泛中和抗体；以及 艾滋病毒预防的综合战略。 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这些具体目标是可以实现的 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流行。