Emory- Duke- Orlando- CDC (EmDOC) Clinical Trials Unit

描述(由申请人提供)：通过这项申请，埃默里大学、杜克大学、奥兰多免疫学中心和疾病控制和预防中心(CDC)正在提议整合八个现有的、高产的艾滋病毒研究网站。埃默里、杜克、奥兰多、疾控中心临床试验中心(EmDOC CTU)的行政核心将设在埃默里大学。CTU将由三名首席调查人员领导：卡洛斯·德尔·里奥、杰弗里·伦诺克斯和马克·J·穆利根。反恐联盟将包括美国东南部的四个研究地点(两个位于亚特兰大，一个位于达勒姆，一个位于奥兰多)和四个国际研究地点(博茨瓦纳、肯尼亚、坦桑尼亚和泰国)。所有这些网站目前都在美国和国际上进行复杂的临床试验， 受艾滋病毒流行以及随之而来的结核病和病毒性肝炎疫情的沉重打击，并可接触到各种受影响严重的人群。 这项计划的具体目标是： 1.为解决这六个关键研究领域--成人艾滋病毒治疗战略，包括艾滋病毒治疗、非传染性合并症以及肝炎和结核病的传染性并存 2.成为促进妇女、少数群体和青少年在国内和低收入和中等收入国家支持网络临床试验的主要CTU。 3.建立一个高效而灵活的技术合作小组，能够对不断变化的研究机会迅速作出反应。 4.参与制定和实施涉及六个优先研究领域的所有NIAID临床研究网络的临床研究计划。 相关性：反恐联盟将与临床研究网络合作，为改进艾滋病毒感染的治疗和潜在治愈战略、结核病和病毒性肝炎的治疗、改进预防艾滋病毒的方法以及改进抗生素耐药感染的治疗作出贡献。这个CTU将为改善美国公众和国际公众的健康做出贡献。

DESCRIPTION (provided by the applicant): Through this application Emory University, Duke University, the Orlando Immunology Center, and the Centers for Disease Control and Prevention (CDC) are proposing an integration of eight existing, highly productive HIV research sites. The administrative core of the Emory, Duke, Orlando, CDC Clinical Trials Unit (EmDOC CTU) will be located at Emory University. The CTU will be led by three Principal Investigators: Carlos del Rio, Jeffrey Lennox, and Mark J. Mulligan. The CTU will include four Southeastern US research sites (2 located in Atlanta, one in Durham, and one in Orlando) and four international research sites (Botswana, Kenya, Tanzania, and Thailand). All of these sites are currently performing complex clinical trials in areas of the United States and internationally that are hard hit by the HIV epidemic, as well as by the concomitant epidemics of TB and viral hepatitis, and have access to diverse heavily affected populations. The Specific Aims of the Project are: 1. To contribute scientific expertise and human subject enrollment into studies that address these six key research areas-Adult HIV therapeutic strategies, including HIV cure, noninfectious comorbidities, and the infectious comorbidities of hepatitis and tuberculosis; Strategies to address HIV and HIV-associated infections in pediatric and maternal populations; Integrated HIV prevention strategies; Microbicide strategies to prevent HIV infection; Vaccines to prevent HIV infection; and Strategies to address antibacterial resistance. 2. To be a leading CTU for contributions of women, minorities and adolescents to support Network clinical trials, both domestically and in low and middle income countries. 3. To operate an efficient and flexible CTU that can respond rapidly to evolving research opportunities. 4. To participate in the development and implementation of the clinical research plans of all of the NIAID clinical research networks that are addressing the six priority research areas. RELEVANCE: The CTU, working with the clinical research networks, will contribute to the development of improved strategies for the treatment and potential cure of HIV infection, to the treatment of TB and viral hepatitis, to improved methods for the prevention of HIV, and to improved treatments for antibiotic resistant infections. This CTU will contribute to improving the health of both the American public and the international public.