Case AIDS Clinical Trials Unit

描述(由申请人提供)：凯斯西储大学建议建立一个临床试验单位(CTU)，在克利夫兰的凯斯/大学医院(UHC)、克利夫兰的MetroHealth医学中心和乌干达坎帕拉的联合临床研究中心(JCRC)设有临床研究站点(CRSS)。这三个地点已被邀请加入艾滋病临床试验小组(ACTG)；CASE/UHC CRS作为高效杀微生物剂开发计划的牵头地点也已被邀请加入杀微生物剂治疗网络(MTN)，尽管未受到正式邀请，但CASE/UHC CRS和JCRC CRS提议与HIV疫苗试验网络(HVTN)一起参与HIV疫苗的试验。自1987年以来，CASE的艾滋病临床试验股(ACTU)作为ACTG的一部分一直得到资助。在此期间，ACTU病例的临床试验表现非常出色。作为最近的一个例子，在过去三年中，该ACTU在ACTG试验的总应计利润中排名第二，在临床试验表现的所有方面都达到或超过了预期。 CASE CTU的压倒一切的主题是将我们机构正在进行的基础和翻译研究的成果带到临床试验研究议程上。该单位在免疫监测、疫苗和其他以免疫为基础的治疗研究、丙型肝炎感染研究和艾滋病毒疾病的代谢并发症研究等领域已经确立了科学实力。因此，毫不奇怪，UHC和MetroHealth医疗中心的CASE及其亚单位在过去三年中对ACTG的科学贡献排名第一。凭借与乌干达临床医生和研究人员17年多的科学合作历史，包括在JCRC开发复杂和富有成效的实验室和临床试验研究基础设施，将该CRS纳入CASE CTU是合理的。由于病例调查人员正在领导艾滋病恶性疾病联盟(AMC)的国际研究工作，同时也领导着口腔艾滋病毒研究联盟(OHARA)，病例CTU将帮助来自不同学科的临床和实验室研究人员聚集在一起，共同解决美国和发展中国家艾滋病毒研究和护理中最引人注目的问题。 管理组件：

DESCRIPTION (provided by applicant): Case Western Reserve University proposes to establish a Clinical Trials Unit (CTU) with clinical research sites (CRSs) at Case/University Hospitals of Cleveland (UHC), MetroHealth Medical Center in Cleveland and the Joint Clinical Research Center (JCRC) in Kampala, Uganda. These three sites have been invited to join the AIDS Clinical Trials Group (ACTG); the Case/UHC CRS as the lead site of a highly productive microbicide development program has also been invited to join the Microbicides Treatment Network (MTN) and though not formally invited, the Case/UHC CRS and the JCRC CRS propose participation with the HIV Vaccine Trials Network (HVTN) in trials of HIV vaccines. The AIDS Clinical Trials Unit (ACTU) at Case has been continuously funded as part of the ACTG since 1987. In this period, the Case ACTU has had a stellar record of clinical trials performance. As a recent example, this ACTU was ranked #2 in total accruals to ACTG trials in the past three years and has always met or exceeded expectations in all aspects of clinical trials performance. The overriding theme of the Case CTU is to bring to the clinical trials research agenda the fruits of basic and translational research that is ongoing at our institutions. Established scientific strengths of the unit have been in the arenas of immunologic monitoring, vaccine and other immune based therapeutic studies, studies of hepatitis C infection and of the metabolic complications of HIV disease. Not surprisingly therefore, Case with its subunits at UHC and MetroHealth Medical Center has been ranked #1 in scientific contributions to the ACTG over the past three years. With a more than 17 year history of scientific collaboration with clinicians and researchers in Uganda that includes the development of a sophisticated and productive laboratory and clinical trials research infrastructure at the JCRC, inclusion of this CRS as a member of the Case CTU is reasonable. As Case investigators are leading the AIDS Malignancy Consortium (AMC) international research effort and also are leading the Oral HIV Research Alliance (OHARA), the Case CTU will help bring together clinical and laboratory researchers from diverse disciplines to address in collaboration the most compelling questions in HIV research and care in the United States and in the developing world. ADMINISTRATIVE COMPONENT: