GHESKIO HIV Clinical Trial Unit

GHESKIO HIV 临床试验中心

• 批准号: 7996530
• 负责人: JEAN WILLIAM PAPE
• 金额: $ 163.87万
• 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 2013-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7996530
• 关键词: AIDS clinical trial group; AIDS prevention; AIDS/HIV problem; Academy; Acquired Immunodeficiency Syndrome; Adolescent; Adult; Africa South of the Sahara; African; Area; Award; Canada; Caribbean region; Caring; Child; Childhood; Chronology; Clinic; Clinical; Clinical Investigator; Clinical Research; Clinical Services; Clinical Trials; Clinical Trials Network; Clinical Trials Unit; Coccidia; Collaborations; Commit; Communities; Comprehensive Health Care; Counseling; Country; Data; Developing Countries; Disease; Enrollment; Female; Fetus; Floor; France; Government; Grant; HIV; HIV Infections; HIV Vaccine Trials Network; HIV-1; Haiti; Health Professional; Health Services Research; Heterosexuals; Housing; Human immunodeficiency virus test; Infection; Institute of Medicine (U.S.); Institution; International; International AIDS; Island; Japan; Kaposi Sarcoma; Laboratories; Leadership; Life; Master of Public Health; Medicine; Modeling; Mothers; Netherlands; Nongovernmental Organizations; Norway; Observational Study; Opportunistic Infections; Patient Care; Patients; Peer Review; Persons; Pharmacy facility; Phase; Phase I/II Trial; Population; Principal Investigator; Procedures; Productivity; Prophylactic treatment; Protocols documentation; Publications; Recruitment Activity; Red Cross; Reporting; Research; Research Infrastructure; Research Personnel; Research Project Grants; Research Training; Science; Screening procedure; Seminal; Seroprevalences; Services; Sexually Transmitted Diseases; Site; Social Welfare; Source; Students; Syphilis; Testing; Therapeutic Human Experimentation; Time; Training; Training Programs; Tuberculosis; United States; United States National Institutes of Health; Universities; Urban Population; Vaccines; Virus; antiretroviral therapy; data management; disease diagnosis; efficacy trial; international center; male; member; meter; next generation; pediatric human immunodeficiency virus; prenatal; prevent; professor; programs; research facility; square foot; 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.

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 两个网络的单中心临床试验单位 (CTU)。两个网络的领导人都强烈支持 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。海地的艾滋病毒/艾滋病发病率是西半球最高的，-4% 的成年人口感染了 B 型 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 多篇经过同行评审的出版物。 GHESKIO 研究人员针对治疗和预防结核病和球虫合并感染的 HIV 感染患者进行了具有里程碑意义的临床试验。海地政府已将 GHESKIO 指定为“公共事业”，这一地位保留给对“海地人民的福祉”至关重要的机构，例如红十字会。 Jean William Pape 博士是该提案的首席研究员。他是 GHESKIO 主任、康奈尔大学医学教授、美国科学院医学研究所成员。 Pape 博士是 ACTG 科学指导委员会的成员，也是 HVTN 功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研究人员进行长期合作。 GHESKIO 自 1997 年起成为 HVTN 成员，自 2002 年起成为 ACTG 成员。它已建立了进行最高质量临床试验的基础设施和程序。 GHESKIO 从现场诊所招募志愿者进行艾滋病毒/艾滋病试验，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，-70% 为女性，约 25% 为青少年。 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职能，例如实验室、数据管理、药学、咨询、管理和财务。 2006-2007 年，GHESKIO 致力于在两个网络中招募并跟踪 630 名志愿者。