GHESKIO HIV Clinical Trial Unit

描述（由申请人提供）：海地太子港的GHESKIO（海地卡波西肉瘤和机会性感染研究小组）正在申请作为附属于HVTN和ACTG两个网络的单点临床试验单位（CTU）。这两个网络的领导人强烈赞成盖斯克独立组织的参加。GHESKIO中心是一个致力于艾滋病毒/艾滋病研究、临床服务和培训的非政府组织。海地是西半球艾滋病毒/艾滋病发病率最高的国家，成年人中有-4%感染了B支艾滋病毒-1。异性传播占主导地位，男女比例为1比1。GHESKIO已经获得了22年不间断的NIH支持，包括NIH优秀奖，并有70多个同行评审的出版物。GHESKIO的研究人员已经开展了具有里程碑意义的治疗和预防艾滋病毒感染结核病和球虫合并感染患者的临床试验。海地政府已指定GHESKIO为“公用事业”，这是为对“海地人民的福利”至关重要的机构保留的地位，例如红十字会。Jean William Pape博士是该提案的首席研究员。他是GHESKIO的主任、康奈尔大学医学教授和美国科学院医学研究所的成员。Pape博士是ACTG科学指导委员会成员，也是HVTN疗效试验工作组的联合主席。GHESKIO CTU将继续与康奈尔大学和范德比尔特大学的调查人员进行长期合作。GHESKIO自1997年以来一直是HVTN的成员，自2002年以来一直是ACTG的成员。它建立了进行最高质量临床试验的基础设施和程序。GHESKIO从现场诊所招募艾滋病毒/艾滋病试验志愿者，每年有23,000名患者接受艾滋病毒自愿咨询和检测。人口为非洲裔，女性占70%，青少年占25%。CTU将为HVTN和ACTG核心以及六个过渡协议提供监督和集中临床研究功能，如实验室、数据管理、药房、咨询、管理和财务。2006-2007年，GHESKIO承诺在两个网络中招募和跟踪630名志愿者。

DESCRIPTION (provided by applicant): GHESKIO (Haitian Study Group for Kaposi's Sarcoma and Opportunistic Infections) in Port au Prince, Haiti is applying as a single site clinical trials unit (CTU) affiliated with two networks, the HVTN and the ACTG. The leaders of the two networks have strongly endorsed GHESKIO's participation. The GHESKIO Centers is a nongovernmental organization dedicated to research, clinical services, and training in HIV/AIDS. Haiti has the highest rates of HIV/AIDS in the Western Hemisphere with -4% of the adult population infected with Clade B HIV-1. Heterosexual transmission predominates with a male to female ratio of 1 to 1. GHESKIO has received 22 years of uninterrupted NIH support including an NIH Merit Award and has over 70 peer-reviewed publications. GHESKIO investigators have conducted landmark clinical trials on the treatment and prophylaxis of HIV-infected patients with tuberculosis and coccidia co-infection. The Haitian Government has designated GHESKIO a "Public Utility", a status reserved for institutions which are essential to the "welfare of the Haitian people", such at the Red Cross. Dr. Jean William Pape is the Principal Investigator of this proposal. He is the Director of GHESKIO, Professor of Medicine at Cornell University, and a member of the US Academy of Science's Institute of Medicine. Dr. Pape is on the ACTG Scientific Steering Committee and is Co-chair of the HVTN Efficacy Trials Working Group. The GHESKIO CTU will continue long-standing collaborations with investigators from Cornell and Vanderbilt Universities. GHESKIO has been a member of the HVTN since 1997 and the ACTG since 2002. It has established the infrastructure and procedures to conduct highest quality clinical trials. GHESKIO recruits volunteers for HIV/AIDS trials from on-site clinics, where 23,000 patients receive HIV voluntary counseling and testing annually. The population is of African descent, -70% female and ~ 25% adolescent. The CTU will provide oversight and centralized clinical research functions such as laboratory, data management, pharmacy, counseling, administration, and finance for the HVTN and ACTG cores and six transition protocols. In 2006-2007, GHESKIO is committed to enroll and follow 630 volunteers in the two networks. ADMINISTRATIVE COMPONENT: