The Military HIV Research Program (MHRP) Clinical Trial Unit

项目摘要 亨利M.杰克逊军事医学促进基金会和 沃尔特里德陆军研究所（WRAIR）建议扩大现有的 美国军事艾滋病毒研究计划（MHRP）临床试验单位（CTU）。拟议的MHRP 反恐组将利用其现有的网络结构，该结构是在以下方面的支持下开发的： 美国陆军、艾滋病部门（DAIDS）和其他部门，延长当前的DAIDS- 资助反恐组的活动当前CTU配置支持艾滋病临床试验组， 两个地点和艾滋病毒/艾滋病疫苗试验网络（HVTN）在其他两个地点。在这个新 根据建议，我们寻求扩大到总共8个站点，所有这些站点都将支持HVTN和 * 艾滋病毒/艾滋病预防试验网络，并将艾滋病毒/艾滋病预防试验网络的附属机构从2个增加到4个 网站.为了更有力地支持结核病治疗和预防的新网络目标， MHRP与IAVI建立了战略合作伙伴关系，以形成强有力的合作， 艾滋病毒和结核病预防新干预措施的科学和发展， 治疗MHRP CTU将包括一个位于WRAIR的核心管理小组， 美国马里兰州和位于非洲的8个国际临床研究中心（CRS） 和亚洲这些研究中心将实施从I期安全性试验到III期的临床方案 有效性试验，并位于艾滋病毒负担严重的地区和适合 参与计划中的预防和治疗临床试验。MHRP的经验和 艾滋病毒疫苗研究的创新，并显示有能力处理新出现的优先事项 艾滋病治疗研究的科学性将有助于DAIDS疫苗和治疗 领导网络。国际艾滋病疫苗倡议将为艾滋病毒预防和结核病疫苗的科学研究做出贡献 领导扩大后的MHRP CTU将带来DAIDS，以及MHRP提议的网络 与国防部和IAVI有联系，具有宝贵的临床研究能力 支持人员。该提案的具体目标包括： 1.提供科学的领导力、新颖的产品和创新的方法。 2.提供艾滋病毒疫苗临床试验网络和艾滋病毒 预防临床试验网络科学议程。 3.提供艾滋病毒/艾滋病成人治疗药物临床试验网络的临床试验执行 科学议程。

Project Summary The Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF) and the Walter Reed Army Institute of Research (WRAIR) propose to extend and diversify the existing U.S. Military HIV Research Program (MHRP) Clinical Trials Unit (CTU). The proposed MHRP CTU will leverage its existing network structure, which has been developed with the support of the United States Army, the Division of AIDS (DAIDS) and others, to extend the current DAIDS- funded CTU activity. The current CTU configuration supports the AIDS Clinical Trials Group at two sites and the HIV/AIDS Vaccine Trial Network (HVTN) at two other sites. In this new proposal, we seek to expand to a total of 8 sites all of which will support both the HVTN and the HIV/AIDS Prevention Trials Network (HPTN) and increase ACTG affiliations from 2 to 4 of these sites. To provide stronger support to the new network goals of TB treatment and prevention, MHRP has formed a strategic partnership with the IAVI to form a potent collaboration supporting both the science and development of novel interventions for both HIV and TB prevention and treatment. The MHRP CTU will comprise a core management group located at WRAIR in Maryland, United States and eight international Clinical Research Sites (CRS) located in Africa and Asia. These sites will implement clinical protocols from phase I safety trials to phase III efficacy trials and are located in areas with substantial HIV burden and populations suitable to participate in planned prevention and therapeutic clinical trials. MHRP’s experience and innovation in HIV vaccine research and demonstrated capability to address emerging priorities of HIV cure research will contribute scientifically to the DAIDS vaccine and therapeutics leadership networks. IAVI will contribute both HIV prevention and TB vaccine scientific leadership. The expanded MHRP CTU will bring DAIDS, and the networks MHRP is proposing affiliation with, valuable clinical research capacity with Department of Defense and IAVI supported staff. Specific aims of the proposal include: 1. Provide scientific leadership, novel products and innovative approaches. 2. Provide clinical trial execution of the HIV Vaccine Clinical Trials Network and the HIV Prevention Clinical Trials Network scientific agenda. 3. Provide clinical trial execution of the HIV/AIDS Adult Therapeutics Clinical Trials Network scientific agenda.