University of Rochester HIV/AIDS Clinical Trials Unit

描述(由申请人提供)：罗切斯特大学临床试验单位(UR CTU)建议与两个NIAID艾滋病毒/艾滋病临床研究网络进行艾滋病毒/艾滋病临床研究，1)‘成人艾滋病毒治疗策略网络’(AHTSN)和2)‘预防艾滋病毒感染疫苗网络’(VPHIN)。CTU将由三个临床研究中心(CRS)组成，其中两个将由罗切斯特大学医学系的“传染病科”运营；一个为“AHTSN”进行治疗研究，另一个为“VPHIN”进行疫苗预防研究。第三个CRS将设在德克萨斯州休斯敦分子病毒学和微生物学系的贝勒医学院(BCM)“疫苗研究中心”，并将进行“VPHIN”的研究。在UR为AHTSN进行治疗研究的CRS将包括来自布法罗大学和AIDS Care，Inc.的合作研究人员。在BCM进行疫苗预防研究的CRS将包括来自德克萨斯大学休斯顿健康科学中心的合作研究人员。CTU的具体目标将是：1)建立和整合在NIAID两个临床研究网络(“AHTSN”和“VPHIN”)下进行临床试验的优秀临床研究网站，以有效推动NIAID艾滋病毒/艾滋病临床研究活动；2)提供杰出的科学、行政和财政领导，对NIAID和‘AHTSN’和‘VPHIN’领导小组作出反应，以推动和加强NIAID艾滋病毒/艾滋病临床研究活动，并进行持续的评估进程，以优化此类活动的表现；3)提供杰出的基础设施(包括实验室、药房、法规遵从性、数据管理、质量管理和工作人员培训)，有效支持NIAID艾滋病毒/艾滋病临床研究活动；4)促进与反恐联盟服务的各个社区的沟通和接触，并促进社区积极参与NIAID艾滋病毒/艾滋病临床研究活动，这包括对罗切斯特和休斯顿整合良好的社区咨询委员会和社区教育项目的支持。 相关性：UR CTU将进行严格、高质量、具有成本效益的伦理临床研究，旨在通过为影响艾滋病毒携带者的医疗条件建立护理标准(在NIAID‘成人HIV治疗策略网络’的领导下)和开发安全有效的预防性HIV疫苗(在NIAID‘预防HIV感染疫苗网络’的领导下)来改善公共健康。

DESCRIPTION (provided by applicant): The University of Rochester Clinical Trials Unit (UR CTU) proposes to conduct HIV/AIDS clinical research with two NIAID HIV/AIDS Clinical Research Networks, 1) the 'Adult HIV Therapeutic Strategies Network' (AHTSN) and 2) the 'Vaccines to Prevent HIV Infection Network' (VPHIN). The CTU will consist of 3 Clinical Research Sites (CRS), two of which will be operated by the 'Infectious Diseases Division' in the Department of Medicine at the University of Rochester; one conducting therapeutic research for the 'AHTSN' and the other conducting vaccine prevention research for the 'VPHIN'. The third CRS will be located at the Baylor College of Medicine (BCM) 'Vaccine Research Center' in the Department of Molecular Virology and Microbiology in Houston, TX and will conduct research for the 'VPHIN'. The CRS conducting therapeutic research for the 'AHTSN' at UR will include collaborating investigators from the University of Buffalo, and AIDS Care, Inc. The CRS conducting vaccine prevention research at BCM will include collaborating investigators from the University of Texas Health Science Center at Houston. The specific aims of the CTU will be to: 1) Establish and integrate outstanding Clinical Research Sites that conduct clinical trials under the two NIAID Clinical Research Networks (the 'AHTSN' and 'VPHIN') to effectively advance NIAID HIV/AIDS clinical research activities; 2) Provide outstanding scientific, administrative and fiscal leadership that is responsive to the NIAID and 'AHTSN' and 'VPHIN' leadership groups to advance and enhance NIAID HIV/AIDS clinical research activities, and to conduct a continuous evaluation process that optimizes performance of such activities, 3) Provide outstanding infrastructure (including laboratory, pharmacy, regulatory compliance, data management, quality management and staff training) that effectively supports NIAID HIV/AIDS clinical research activities at the UR and BCM, and 4) Stimulate communication and engagement with the full range of communities that the CTU serves, and to promote robust community participation in NIAID HIV/AIDS clinical research activities, which includes the support of well-integrated Community Advisory Boards and community education programs in Rochester and Houston. RELEVANCE: The UR CTU will conduct rigorous, high-quality, cost-effective ethical clinical research designed to improve public health by contributing to the establishment of standards-of-care for medical conditions affecting people living with HIV (under the leadership of the NIAID 'Adult HIV Therapeutic Strategies Network') and the development of a safe and effective preventive HIV vaccine (under the leadership of the NIAID 'Vaccines to Prevent HIV Infection Network').