University of Rochester HIV/AIDS Clinical Trials Unit

描述（由申请人提供）：罗彻斯特大学临床试验单位（UR CTU）建议与NIAID的两个HIV/AIDS临床研究网络进行HIV/AIDS临床研究，1)“成人HIV治疗策略网络”（AHTSN）和2)“预防HIV感染疫苗网络”（VPHIN）。CTU将由3个临床研究站点（CRS）组成，其中两个将由罗切斯特大学医学系的“传染病部”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将位于德克萨斯州休斯顿的贝勒医学院（BCM）分子病毒学和微生物学部门的“疫苗研究中心”，并将为“VPHIN”进行研究。在乌拉尔进行“AHTSN”治疗研究的CRS将包括来自布法罗大学和艾滋病护理公司的合作研究人员。在BCM进行疫苗预防研究的CRS将包括来自休斯顿德克萨斯大学健康科学中心的合作研究人员。CTU的具体目标是：1)建立和整合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站点，有效推进NIAID HIV/AIDS临床研究活动；2)提供优秀的科学、行政和财政领导，以响应NIAID、“AHTSN”和“VPHIN”领导小组，推进和加强NIAID艾滋病毒/艾滋病临床研究活动，并开展持续的评估过程，优化这些活动的绩效；4)促进与CTU服务的所有社区的沟通和参与，并促进社区积极参与NIAID艾滋病毒/艾滋病临床研究活动，其中包括对罗切斯特和休斯顿良好整合的社区咨询委员会和社区教育项目的支持。

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').