The Military HIV Research Program (MHRP) Clinical Trial Unit

军事艾滋病毒研究计划 (MHRP) 临床试验单位

• 批准号: 10057645
• 负责人: Julie A. Ake
• 金额: $ 227.27万
• 依托单位: HENRY M. JACKSON FDN FOR THE ADV MIL/MED
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-12-10 至 2027-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10057645
• 关键词: AIDS clinical trial group; AIDS prevention; AIDS/HIV problem; Acquired Immunodeficiency Syndrome; Active Immunization; Address; Adjuvant; Adult; Africa; Area; Asia; Cell Cycle; Clinical; Clinical Protocols; Clinical Research; Clinical Trials; Clinical Trials Cooperative Group; Clinical Trials Network; Clinical Trials Unit; Cohort Studies; Collaborations; Communicable Diseases; Complement; Data; Department of Defense; Development; Disease Progression; Epidemic; Foundations; Funding; Goals; Group Affiliation; HIV; HIV Infections; HIV vaccine; HIV/TB; Health Services Accessibility; Hepatitis; Immunity; International; Intervention; Kenya; Leadership; Maryland; Military Medicine; Military Personnel; Mozambique; National Security; Passive Immunization; Phase; Phase I Clinical Trials; Population; Prevention; Prevention Research; Prevention trial; Protein Subunits; Research; Research Infrastructure; Research Institute; Role; Safety; Sampling; Sampling Studies; Science; Site; Structure; Subunit Vaccines; Tanzania; Technology; Therapeutic; Therapeutic Clinical Trial; Therapeutic Studies; Tuberculosis; Tuberculosis Vaccines; U-Series Cooperative Agreements; United States; Vaccine Research; Vaccines; acute infection; animal data; clinical research site; comorbidity; cost effective; efficacy trial; experience; human data; innovation; insight; mortality; novel; phase 1 study; pre-exposure prophylaxis; programs; response; support network; tuberculosis treatment; vaccine trial; vector

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.

项目概要 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) 提议扩展现有的研究中心并使其多样化 美国军事艾滋病毒研究计划 (MHRP) 临床试验单位 (CTU) 拟议的 MHRP。 CTU 将利用其现有的网络结构，该结构是在 美国陆军、艾滋病司 (DAIDS) 和其他机构，以延长目前的 DAIDS- 资助的 CTU 活动 目前的 CTU 配置支持 AIDS 临床试验小组。 两个地点和另外两个地点的艾滋病毒/艾滋病疫苗试验网络 (HVTN)。 根据提案，我们寻求扩展到总共 8 个站点，所有这些站点都将支持 HVTN 和 HIV/艾滋病预防试验网络 (HPTN) 并将 ACTG 附属机构从 2 个增加到 4 个 为结核病治疗和预防的新网络目标提供更有力的支持， MHRP 与 IAVI 建立了战略合作伙伴关系，以形成强有力的合作支持 艾滋病毒和结核病预防的科学和新型干预措施的发展 MHRP CTU 将由位于 WRAIR 的核心管理小组组成。 美国马里兰州和位于非洲的八个国际临床研究中心 (CRS) 这些地点将实施从第一阶段安全试验到第三阶段的临床方案。 功效试验，并位于艾滋病毒负担重的地区和适合人群 参与 MHRP 的预防计划和治疗性临床试验。 HIV 疫苗研究的创新和解决新兴优先事项的能力 HIV治愈研究将为DAIDS疫苗和治疗做出科学贡献 IAVI 领导网络将为艾滋病毒预防和结核病疫苗科学做出贡献。 扩大后的 MHRP CTU 将带来 DAIDS，以及 MHRP 提议的网络。 与国防部和 IAVI 具有宝贵的临床研究能力 该提案的具体目标包括： 1. 提供科学领先、新颖的产品和创新的方法。 2. 提供HIV疫苗临床试验网络和HIV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。