Units for HIV/AIDS Clinical Trials Networks

HIV/AIDS 临床试验网络单位

• 批准号: 8464936
• 负责人: MICHAEL C KEEFER
• 金额: $ 7.38万
• 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/8464936
• 关键词: AIDS clinical trial group; AIDS/HIV problem; Acquired Immunodeficiency Syndrome; Area; Brazil; Buffaloes; Clinical Research; Clinical Trials; Clinical Trials Network; Clinical Trials Unit; Communicable Diseases; Community Health Centers; Community Health Education; Community Outreach; Data Quality; Disease; Enrollment; Flow Cytometry; Goals; HIV Infections; HIV Vaccine Trials Network; HIV vaccine; Laboratories; Leadership; Letters; Medical center; Mentors; National Institute of Allergy and Infectious Disease; New York; Performance; Prevention; Principal Investigator; Process; Recording of previous events; Research; Research Personnel; Research Support; Resource Sharing; Training; Universities; base; clinical research site; design; effective therapy; outreach program; patient population; prevent; programs; vaccine development

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.

UR CTU将由一个行政部门和四个临床研究中心（CRS）组成。乌拉圭回合 CTU建议加入HIV疫苗试验网络（HVTN）和艾滋病临床试验网络（AIDS Clinical Trials）。 组（ACTG）。HVTN首席研究员Larry Corey博士和HVTN首席研究员Larry Corey博士的承诺书 ACTG的首席研究员Constance Benson被列入“顾问和 支持信”。在四个UR CTU CRS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HIV的主要单位或亚单位。 疫苗试验单位（HVTU）或艾滋病临床试验单位（ACTU）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 HVTN CRS。 ACTG CRS将开展ACTG研究。第三个CRS将设在艾滋病社区卫生中心 （ACHC），在罗切斯特，纽约，并将进行ACTG研究。第四个将位于国家 纽约大学布法罗分校，UB CRS，并将进行ACTG研究。行政核心 乌尔CTU将设在乌尔传染病司（IDD）内，该司还包括 UR HVTN CRS和UR ACTG CRS。UR IDD在执行NIAID支持的 临床研究，并一直是HVTN和ACTG的一部分，因为这两个项目的起源。作为 由于这段历史，IDD开发了共享资源的方法，这将是 在提议的反恐组中扩大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 教育和推广方案以及工作人员培训办法。这些功能将是 由四个CRS共享。CTU将支持HVTN和ACTG中提出的研究议程 领导力通过在批判性研究中招收科目的应用，重点放在UR CTU 调查人员具有特殊的专门知识和经证实的业绩记录。UR CTU调查员 也将为HVTN和ACTG做出重要的科学和行政贡献。反恐组 将作为设在巴西圣保罗圣保罗联邦大学的反恐小组的指导单位。 本提案中概述的研究旨在为预防和治疗 艾滋病毒感染和艾滋病。拟议中的UR CTU将与两个大型的多中心项目合作， HVTN和ACTG。HVTN的目标是开发一种预防艾滋病毒感染的疫苗， 延迟症状性疾病的发作。ACTG的目标是开发更有效的治疗方法， 在各种患者人群中建立HIV感染。