Units for HIV/AIDS Clinical Trials Networks

HIV/AIDS 临床试验网络单位

• 批准号: 7345412
• 负责人: MICHAEL C KEEFER
• 金额: $ 224.85万
• 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/7345412
• 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)临床试验单位(CTU)的创建。UR CTU将由一个行政部门和四个临床研究网站(CRSS)组成。UR CTU正在提议加入HIV疫苗试验网络(HVTN)和艾滋病临床试验小组(ACTG)。咨询公司首席调查员拉里·科里博士和咨询小组首席调查员康斯坦斯·本森博士的承诺书包括在“顾问和支持函”一节中。在四个UR CTU CRSS中，一个将为HVTN进行研究，三个将为ACTG进行研究。所有四个CRS目前都是现有的艾滋病毒疫苗试验单位(HVTU)或艾滋病临床试验单位(ACTU)的主要单位或亚单位。两个CRSS将设在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将设在纽约罗切斯特的艾滋病社区卫生中心(ACHC)，并将进行ACTG研究。第四个将设在纽约州立大学布法罗分校，UB CRS，将进行ACTG研究。UR CTU的行政核心将设在UR传染病科(IDD)内，该科还包括UR HVTN CRS和UR ACTG CRS。UR IDD在进行NIAID支持的临床研究方面有很长的历史，自从这两个项目开始以来，它一直是HVTN和ACTG的一部分。作为这一历史的结果，IDD制定了共享资源的方法，并将在拟议的CTU中扩大这种方法。集中的临床研究职能将包括处理实验室、流式细胞仪实验室、数据和质量管理团队、社区教育和外联计划(CEOP)以及工作人员培训方法。这些职能将由所有四个中央审查委员会共享。CTU将支持在HVTN和ACTG领导力申请中提出的研究议程，将受试者纳入关键研究，重点关注UR CTU调查人员具有特殊专长和表现良好的领域。我们的反恐小组调查员还将为HVTN和ACTG做出重要的科学和行政贡献。UR CTU将作为总部设在巴西圣保罗联邦大学的CTU的指导单位。这项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。拟议的UR CTU将隶属于两个大型的多中心项目，即HVTN和ACTG。HVTN的目标是开发一种疫苗，防止艾滋病毒感染或推迟症状性疾病的发生。ACTG的目标是为各种患者群体中已确定的艾滋病毒感染开发更有效的治疗方法。 管理组件：