The Military HIV Research Program (MHRP) Clinical Trial Unit

项目摘要 亨利·杰克逊军事医学促进基金会(HJF)和 沃尔特里德陆军研究所(WRAIR)建议扩展和多样化现有的 美国军方艾滋病毒研究计划(MHRP)临床试验单位(CTU)。建议的MHRP CTU将利用其现有的网络结构，该网络结构是在 美国陆军、艾滋病司(DAIDS)和其他机构，将目前的DAIDS- 资助了CTU的活动。目前的CTU配置支持艾滋病临床试验小组，地址为 两个站点和另外两个站点的艾滋病毒/艾滋病疫苗试验网络。在这个新的 建议，我们寻求扩大到总共8个地点，所有这些地点都将支持HVTN和 艾滋病毒/艾滋病预防试验网络(HPTN)，并将ACTG从属关系从2个增加到4个 网站。为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，形成了强有力的合作，支持 艾滋病毒和结核病预防和预防的新干预措施的科学和开发 治疗。MHRP CTU将组成一个核心管理小组，位于#年WRAIR 美国马里兰州和位于非洲的八个国际临床研究基地(CRS) 和亚洲。这些地点将执行从第一阶段安全试验到第三阶段的临床方案。 有效性试验，并位于艾滋病毒负担较大的地区和适合 参与有计划的预防和治疗临床试验。MHRP的经验和 艾滋病毒疫苗研究方面的创新，并展示了解决新出现的优先事项的能力 HIV治愈研究将为DAIDS疫苗和治疗方法做出科学贡献 领导力网络。IAVI将为艾滋病毒预防和结核病疫苗的科学研究做出贡献 领导力。扩大的MHRP CTU将带来DAIDS，以及MHRP建议的网络 隶属于国防部和IAVI，拥有宝贵的临床研究能力 得到支持的员工。该提案的具体目标包括： 1.提供科学引领、创新产品和创新方法。 2.提供艾滋病毒疫苗临床试验网络和艾滋病毒的临床试验执行 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.