WASHINGTON UNIVERSITY AIDS CLINICAL TRIALS UNIT

描述(由申请者提供)：这份申请将在未来七年内继续为圣路易斯华盛顿大学医学院现有的艾滋病临床试验单位提供捐助。我们建议成立一个临床试验股，其行政结构由David Clifford博士领导，促进对艾滋病临床试验小组(ACTG)网络(100%)的积极贡献，该网络是在响应康斯坦斯·本森博士领导的RFA AI-05-001的申请中提出的。我们将通过招募、筛选和招募研究参与者进行临床研究，以响应以下领域的临床研究计划：(1)转译研究/药物开发，(-25)(2)优化临床管理，包括共病，(~55%)(2)预防母婴传播(~10%)(4)疫苗研发。(~5%)和(5)预防感染(5%)。本申请描述了华盛顿大学医学院的一个单一临床研究站点(CRS)，该站点将执行本研究议程的所有部分。CRS应用程序包括在上述研究领域以典型方案招募、筛选和登记20名受试者的计划，以及目前支持ACTG系统组织的100多名受试者的持续试验的持续工作。圣路易斯CTU还将发挥科学领导作用，协助翻译研究的发展，特别强调包括神经系统疾病、肝炎、心血管和代谢并发症在内的并存疾病。将继续在艾滋病毒新疗法以及艾滋病毒疾病的儿科和青少年表现领域发展更多的科学领导和专门知识。在这项申请下，将继续为一个重要的社区咨询委员会提供持续支助，确保建设性地接触受影响人口的咨询意见和咨询，并向受影响人口提供外联和教育支持。为这项申请提供资金将使华盛顿大学艾滋病研究界不断作出贡献，将关键的科学概念转化为最佳实施，造福所有艾滋病毒感染者。我们期待着治疗方面的改进，这将改善我们自己的社区、国家以及受艾滋病毒/艾滋病影响的更大的国际社区的健康。 管理组件：

DESCRIPTION (provided by applicant): This application will continue the contributions of an existing AIDS Clinical Trails Unit at Washington University School of Medicine in St. Louis for the next seven years. We propose a Clinical Trial Unit with an administrative structure led by Dr. David Clifford facilitating active contribution to the AIDS Clinical Trials Group (ACTG) network (100%) proposed in an application responding to RFA AI-05-001 headed by Dr. Constance Benson. We will conduct clinical research by recruiting, screening, and enrolling research participants in trials responding to clinical research plans in the following areas: (1) Translational Research/Drug Development, (-25) (2) Optimization of Clinical Management, Including Co-Morbidities,(~55%) (2)Prevention of Mother-to-Child Transmission(~10%) (4) Vaccine Research and Development. (~5%) and (5) Prevention of Infection (5%). This application describes a single Clinical Research Site (CRS) at Washington University School of Medicine that will carry out all portions of this research agenda. The CRS application includes plans for recruiting, screening, and enrolling 20 subjects in typical protocols in the above research areas, as well as ongoing work supporting continuing trials organized by the ACTG system with in excess of100 participating subjects at the present time. The St. Louis CTU will also contribute to scientific leadership assisting development of translational research with particular emphasis on the co-morbidities including neurologic conditions, hepatitis, cardiovascular and metabolic complications. Additional scientific leadership and expertise will continue to be developed in areas of new HIV therapies and pediatric and adolescent manifestations of HIV disease. Ongoing support for a vital Community Advisory Board will be continued under this application, assuring the constructive engagement for advise and counsel from affected populations, as well as providing outreach and educational support to affected populations. Funding this application will provide for ongoing contributions of the Washington University AIDS research community in translation of critical scientific concepts to optimal implementation to the benefit of all persons with HIV infection. We anticipate improvements in therapy that will improve the health in our own community, country, and in the much larger international community affected by HIV/AIDS. ADMINISTRATIVE COMPONENT: