Units for HIV/AIDS Clinical Trials Networks

HIV/AIDS 临床试验网络单位

• 批准号: 7097857
• 负责人: Richard C. Reichman
• 金额: $ 256.85万
• 依托单位: UNIVERSITY OF ROCHESTER
• 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 2013-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7097857
• 关键词: AIDS clinical trial group; AIDS/HIV problem; Acquired Immunodeficiency Syndrome; Area; Brazil; Buffaloes; Category Rating Scale; Clinical Research; Clinical Trials; Clinical Trials Network; Communicable Diseases; Community Health Centers; Community Health Education; Data Quality; Disease; Education and Outreach; Enrollment; Flow Cytometry; Goals; HIV Infections; HIV vaccine; Laboratories; Leadership; Letters; Medical center; Mentors; New York; Patients; Performance; Population; Prevention; Principal Investigator; Process; Recording of previous events; Research; Research Personnel; Resource Sharing; Support of Research; Training; Universities; Vaccines; base; clinical research site; design; outreach program; prevent; programs

DESCRIPTION (provided by applicant): This application describes the creation of the University of Rochester (UR) Clinical Trials Unit (CTU). The UR CTU will consist of an Administrative Component and four Clinical Research Sites (CRSs). The UR CTU is proposing to affiliate with the HIV Vaccine Trials Network (HVTN) and the AIDS Clinical Trials Group (ACTG). Letters of commitment from Dr. Larry Corey, Principal Investigator of the HVTN, and Dr. Constance Benson, Principal Investigator of the ACTG, are included in the Section "Consultants and Letters of Support". Of the four UR CTU CRSs, one will conduct studies for the HVTN and three will conduct studies for the ACTG. All four CRSs are currently main units or subunits of an existing HIV Vaccine Trials Unit (HVTU) or AIDS Clinical Trials Unit (ACTU). Two CRSs will be located at the UR Medical Center (URMC). One, the UR HVTN CRS, will conduct HVTN studies, and the other, the UR ACTG CRS will conduct ACTG studies. The third CRS will be located at AIDS Community Health Center (ACHC), in Rochester, New York and will perform ACTG studies. The fourth will be located at the State University of New York at Buffalo, the UB CRS, and will perform ACTG studies. The Administrative Core of the UR CTU will be located within the UR Infectious Diseases Division (IDD), which also contains the UR HVTN CRS and the UR ACTG CRS. The UR IDD has a long history of performing NIAID-supported clinical investigation and has been part of the HVTN and ACTG since both programs originated. As a consequence of this history, the IDD has developed approaches to sharing resources, which will be expanded in the proposed CTU. Centralized Clinical Research Functions will include a Processing Laboratory, a Flow Cytometry Laboratory, a Data and Quality Management Team, a Community Education and Outreach Program (CEOP), and an approach to Staff Training. These Functions will be shared by all four CRSs. The CTU will support the research agendas proposed in the HVTN and ACTG Leadership Applications by enrolling subjects in critical studies, focusing on areas in which UR CTU investigators have particular expertise and a demonstrated record of performance. UR CTU investigators will also make important scientific and administrative contributions to the HVTN and ACTG. The UR CTU will serve as a mentoring unit for a CTU based at the Federal University of Sao Paulo in Sao Paulo, Brazil. The research outlined in this proposal is designed to make contributions to the prevention and treatment of HIV infection and AIDS. The proposed UR CTU will affiliate with two large, multicentered programs, the HVTN and the ACTG. The goal of the HVTN is to develop a vaccine that will prevent HIV infection or delay the onset of symptomatic disease. The goal of the ACTG is to develop more effective treatments for established HIV infection in a variety of patient populations. ADMINISTRATIVE COMPONENT:

描述（由申请人提供）：本申请描述了罗切斯特大学（UR）临床试验部门（CTU）的创建。UR CTU将由一个行政部门和四个临床研究中心（CRS）组成。UR CTU建议加入艾滋病毒疫苗试验网络（HVTN）和艾滋病临床试验组（ACTG）。HVTN的主要研究者Larry Corey博士和ACTG的主要研究者Constance Benson博士的承诺信包含在“顾问和支持信”部分。在四个UR CTU CRS中，一个将进行HVTN研究，三个将进行ACTG研究。所有四个CRS目前都是现有艾滋病毒疫苗试验单位（HVTU）或艾滋病临床试验单位（ACTU）的主要单位或子单位。两个CRS将位于UR医疗中心（URMC）。一个是UR HVTN CRS，将进行HVTN研究，另一个是UR ACTG CRS，将进行ACTG研究。第三个CRS将位于纽约罗切斯特的艾滋病社区卫生中心（ACHC），并将进行ACTG研究。第四个将设在布法罗的纽约州立大学，即UB CRS，并将进行ACTG研究。UR CTU的行政核心将设在UR传染病司（IDD）内，该司还包括UR HVTN CRS和UR ACTG CRS。UR IDD在进行NIAID支持的临床研究方面有着悠久的历史，并且自HVTN和ACTG项目启动以来一直是这两个项目的一部分。由于这段历史，IDD开发了共享资源的方法，并将在拟议的CTU中扩展。集中临床研究职能将包括处理实验室、流式细胞术实验室、数据和质量管理团队、社区教育和外展计划（CEOP）以及员工培训方法。这些职能将由所有四个CRS共享。CTU将支持HVTN和ACTG领导力应用程序中提出的研究议程，方法是在批判性研究中招募受试者，重点关注UR CTU调查人员具有特殊专业知识和表现记录的领域。UR CTU研究人员还将为HVTN和ACTG做出重要的科学和行政贡献。乌拉圭工会联合会将作为设在巴西圣保罗圣保罗联邦大学的工会联合会的指导单位。本提案中概述的研究旨在为艾滋病毒感染和艾滋病的预防和治疗做出贡献。拟议中的UR CTU将与两个大型的多中心项目HVTN和ACTG建立联系。HVTN的目标是开发一种预防HIV感染或延迟症状性疾病发作的疫苗。ACTG的目标是为各种患者人群中已确定的HIV感染开发更有效的治疗方法。 行政部门：