Case AIDS Clinical Trials Unit

描述（由申请人提供）： 凯斯西储大学提议在克利夫兰凯斯/大学医院（UHC）、克利夫兰MetroHealth医疗中心和乌干达坎帕拉联合临床研究中心（JCRC）建立一个临床试验单位（CTU），并设立临床研究中心（CRS）。这三个研究中心已被邀请加入艾滋病临床试验组（ACTG）; Case/UHC CRS作为高效杀微生物剂开发计划的牵头研究中心也被邀请加入杀微生物剂治疗网络（MTN），尽管没有正式邀请，但Case/UHC CRS和JCRC CRS提议与HIV疫苗试验网络（HVTN）一起参与HIV疫苗试验。自1987年以来，艾滋病临床试验单位（ACTU）一直作为ACTG的一部分获得资助。在此期间，Case ACTU在临床试验方面取得了出色的成绩。作为最近的一个例子，该ACTU在过去三年中在ACTG试验的总应计费用中排名第二，并且在临床试验性能的各个方面始终达到或超过预期。 Case CTU的首要主题是将我们机构正在进行的基础和转化研究的成果带入临床试验研究议程。该单位的既定科学优势一直在免疫监测，疫苗和其他免疫治疗研究，丙型肝炎感染和艾滋病毒疾病的代谢并发症的研究领域。因此，毫不奇怪，在过去的三年里，凯斯及其在UHC和MetroHealth医疗中心的子单位在ACTG的科学贡献中排名第一。与乌干达的临床医生和研究人员有着超过17年的科学合作历史，包括在JCRC开发了一个先进而富有成效的实验室和临床试验研究基础设施，因此将该CRS纳入病例CTU是合理的。由于Case研究人员正在领导艾滋病研究联盟（AMC）的国际研究工作，并正在领导口服艾滋病毒研究联盟（大原），Case CTU将帮助汇集来自不同学科的临床和实验室研究人员，以合作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。 行政部门：

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: