GHESKIO HIV Clinical Trial Unit

GHESKIO HIV 临床试验中心

• 批准号: 8195400
• 负责人: JEAN WILLIAM PAPE
• 金额: $ 160.49万
• 依托单位: GHESKIO CENTER
• 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 2012-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8195400
• 关键词: AIDS clinical trial group; AIDS/HIV problem; Academy; Adolescent; Adult; African; Award; Clinic; Clinical Research; Clinical Services; Clinical Trials; Clinical Trials Unit; Coccidia; Collaborations; Commit; Counseling; Enrollment; Female; Government; HIV; HIV Vaccine Trials Network; HIV-1; Haiti; Heterosexuals; Infection; Institute of Medicine (U.S.); Institution; Kaposi Sarcoma; Laboratories; Medicine; Nongovernmental Organizations; Opportunistic Infections; Patients; Peer Review; Pharmacy facility; Population; Principal Investigator; Procedures; Prophylactic treatment; Protocols documentation; Publications; Recruitment Activity; Red Cross; Research; Research Infrastructure; Research Personnel; Science; Site; Social Welfare; Testing; Training; Tuberculosis; United States National Institutes of Health; Universities; data management; efficacy trial; male; member; professor; transmission process; volunteer; working group

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:

描述（由申请人提供）：位于海地太子港的GHESKIO（海地卡波西肉瘤和寄生虫感染研究组）正在申请作为一个单一的临床试验单位（CTU），隶属于HVTN和ACTG两个网络。这两个网络的领导人强烈支持GHESKIO的参与。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/艾滋病感染率最高的国家，约有4%的成年人感染了进化枝B HIV-1。异性传播占主导地位，男女比例为1比1。GHESKIO获得了22年不间断的NIH支持，包括NIH优异奖，并拥有70多篇同行评审的出版物。GHESKIO的研究人员已经进行了具有里程碑意义的临床试验，用于治疗和预防结核病和球虫合并感染的艾滋病毒感染患者。海地政府指定GHESKIO为“公用事业”，这一地位是为对“海地人民的福利”至关重要的机构保留的，如红十字会。Jean William Pape博士是该提案的主要研究者。他是GHESKIO的主任，康奈尔大学医学教授，以及美国科学院医学研究所的成员。Pape博士是ACTG科学指导委员会的成员，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成员，自2002年以来一直是ACTG成员。它建立了基础设施和程序，以进行最高质量的临床试验。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，约70%为女性，约25%为青少年。CTU将为HVTN和ACTG核心和六个过渡方案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承诺在这两个网络中招募和跟踪630名志愿者。 行政部门：