WASHINGTON UNIVERSITY AIDS CLINICAL TRIALS UNIT

描述（由申请人提供）：该申请将在未来七年内继续圣路易斯华盛顿大学医学院现有的艾滋病临床试验单位的贡献。我们建议建立一个临床试验单位，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，该网络是在响应由Constance Benson博士领导的RFA AI-05-001的申请中提出的。我们将根据以下领域的临床研究计划，通过招募、筛选和招募研究参与者来开展临床研究：(1)转化研究/药物开发，（- 25%）(2)临床管理优化，包括合并症，（~55%）(2)母婴传播预防（~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临床研究站点（CRS），该站点将执行本研究议程的所有部分。CRS申请包括在上述研究领域的典型方案中招募、筛选和招募20名受试者的计划，以及支持ACTG系统组织的持续试验的正在进行的工作，目前参与试验的受试者超过100名。圣路易斯CTU还将为科学领导做出贡献，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合并症。将继续在新的艾滋病毒疗法和儿童和青少年艾滋病毒疾病表现方面发展更多的科学领导和专门知识。根据这一申请，将继续为一个至关重要的社区咨询委员会提供持续支持，确保受影响人群建设性地参与建议和咨询，并为受影响人群提供外联和教育支持。资助这一申请将为华盛顿大学艾滋病研究界提供持续的贡献，将关键的科学概念转化为最佳实施，使所有艾滋病毒感染者受益。我们预期治疗的改进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会的健康。

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: