University of Cincinnati AIDS Clinical Trials Unit- UC ACTU

描述(由申请人提供)： 美国每年约有40-6万新的艾滋病毒感染病例，约有110万艾滋病毒携带者。有许多重要的尚未解决的管理问题，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、合并症的治疗以及将药物相关毒性降至最低。辛辛那提大学艾滋病临床试验中心(UC ACTU)自1987年以来一直是NIAID资助的艾滋病临床试验小组(ACTG)网站。在这项申请中，加州大学ACTU建议建立一个临床试验单位(CTU)和临床研究网站(CRS)，附属于ACTG领导应用程序。这家经验丰富的CTU在过去3年中在ACTG的34个主要单位中的总应计成本排名第五，单位加权成本成本排名第三，它将继续以其模范表现、科学和资源委员会的贡献为基础，在世界级临床试验网络(ACTG)中发挥领导作用，其科学目标是开发新的治疗方法(转化研究/药物开发)；优化临床管理，包括毒性和共病；预防母婴传播；以及疫苗研发。为了实现ACTG的目标，UC ACTU将：1)建立一个行政核心CTU，包括首席研究员、临床试验经理、监管经理、数据/质量保证经理、工作人员培训和教育、标本处理、社区推广和行政支持，以提供所需的监督、协调和科学专业知识，以运作一个与ACTG的总体议程/工作相衔接的高绩效CTU；2)通过招募研究对象、提出新的建议、参与研究小组和委员会以推进小组的工作，为ACTG的科学议程作出贡献；3)建立每月可保持20个研究对象的CRS，有能力每年跟踪100个对象，重点关注代表不足的人群，并利用临床研究单位良好临床实践的最高标准。因此，加州大学ACTU由经验丰富的艾滋病毒临床研究员朱迪思·范伯格博士领导，并得到肝炎(Ken Sherman博士)和艾滋病毒相关血脂异常/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艾滋病毒感染者的生活做出贡献。 管理组件：

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: