University of Cincinnati AIDS Clinical Trials Unit- UC ACTU

描述（由申请人提供）： 美国每年约有40- 60，000例新的艾滋病毒感染，约有110万人感染艾滋病毒。有许多尚未解决的重要管理问题，包括艾滋病毒疾病不同阶段的最佳抗逆转录病毒治疗策略、合并症的治疗和尽量减少药物相关毒性。辛辛那提大学艾滋病临床试验单位（UC ACTU）自1987年以来一直是NIAID资助的艾滋病临床试验组（ACTG）网站。在本申请中，UC ACTU提议建立一个附属于ACTG领导申请的临床试验单位（CTU）和临床研究中心（CRS）。 这个经验丰富的CTU，在过去3年中，在34个主要ACTG单位中，总应计费用排名第5，每加权应计费用排名第3，将继续建立其模范绩效，科学和资源委员会贡献，在世界级临床试验网络（ACTG）中提供领导，以开发新的治疗方法的科学目标（转化研究/药物开发）;优化临床管理，包括毒性和合并症;预防母婴传播;以及疫苗研究和开发。为了实现ACTG的目标，UC ACTU将：1）建立一个行政核心CTU，包括主要研究者、临床试验经理、监管经理、数据/质量保证经理、员工培训和教育、标本处理、社区外展和行政支持，以提供监督，协调和科学专业知识，以运作一个高绩效的CTU，与ACTG的总体议程/工作相结合; 2）通过在研究中招募受试者，为ACTG的科学议程做出贡献，提出新的建议，参与研究小组和委员会，以推进小组的工作; 3）建立CRS，每月可维持20例受试者参与研究，每年可跟踪100例受试者，重点招募以下受试者-代表人群并使用临床研究单位的最高标准药物临床试验质量管理规范。因此，UC ACTU由经验丰富的HIV临床研究人员Judith Feinberg博士领导，并得到肝炎（Ken谢尔曼博士）和HIV相关血脂异常/心血管疾病（Carl Fichtenbaum博士）领域领先专家的支持，将通过其卓越的临床研究为改善HIV感染者的生活做出贡献。 行政部门：

DESCRIPTION (provided by applicant): Each year there are ~40-60,000 new HIV infections in the United States with ~1.1 million persons living with HIV. There are many important unresolved management issues including the optimal antiretroviral treatment strategy at different stages of HIV disease, treatment of co-morbidities and minimizing of drug-associated toxicities. The University of Cincinnati AIDS Clinical Trials Unit (UC ACTU) has been an NIAID-funded AIDS Clinical Trials Group (ACTG) site since 1987. In this application the UC ACTU proposes to establish a Clinical Trials Unit (CTU) and Clinical Research Site (CRS) affiliated with the ACTG leadership application. This highly-experienced CTU, which was 5th in overall accrual and 3rd in cost per weighted accrual among 34 main ACTG units over the last 3 years, will continue to build upon its exemplary performance, scientific and resource committee contributions to provide leadership within a world-class clinical trials network (ACTG) with the scientific goals of developing new therapeutic approaches (translational research/drug development); optimizing clinical management including toxicities and co-morbidities; preventing maternal-child transmission; and vaccine research and development. To accomplish the goals of the ACTG the UC ACTU will: 1) Establish an administrative core CTU including a principal investigator, clinical trials manager, regulatory manager, data/Quality assurance manager, staff training and education, specimen processing, community outreach and administrative support to provide oversight, coordination and scientific expertise required to operate a high-performing CTU that will interface with the overall agenda/work of the ACTG; 2) Contribute to the ACTG scientific agenda by enrolling subjects in studies, generating new proposals participating in study teams and committees to advance the work of the group; 3) Establish a CRS that can maintain 20 subjects on study per month with the capability of following 100 subjects annually focusing enrollment on under-represented populations and utilizing the highest standards of good clinical practice for clinical research units. Thus, the UC ACTU, led by Dr. Judith Feinberg, an experienced HIV clinical researcher with support from leading experts in the fields of hepatitis (Dr. Ken Sherman) and HIV associated dyslipidemia/ cardiovascular disease (Dr. Carl Fichtenbaum), will contribute to the improvement in the lives of those with HIV infection through its excellence in clinical research. ADMINISTRATIVE COMPONENT: