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: 10306346
• 负责人: Julie A. Ake
• 金额: $ 217.4万
• 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/10306346
• 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.

项目摘要 亨利·杰克逊（Henry M. Jackson）的军事医学发展基金会（HJF）和 沃尔特·里德（Walter Reed）陆军研究所（WRAIR）提议扩展和多样化现有的 美国军事艾滋病毒研究计划（MHRP）临床试验部（CTU）。拟议的MHRP CTU将利用其现有的网络结构，并在 美国陆军，艾滋病（DAIDS）和其他部门，以扩展当前的不同 资助的CTU活动。当前的CTU配置支持AIDS临床试验组 另外两个地点的两个地点和HIV/AIDS疫苗试验网络（HVTN）。在这个新的中 提案，我们试图将总共8个站点扩展到所有这些站点，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（HPTN），并将ACTG分支机构从其中2个增加到4个 站点。为了为结核病治疗和预防的新网络目标提供大力支持， MHRP与IAVI建立了战略合作伙伴关系，以形成潜在的协作支持 艾滋病毒和结核病预防的新干预措施的科学和发展以及 治疗。 MHRP CTU将组成位于Wrair的核心管理小组 美国马里兰州和位于非洲的八个国际临床研究网站（CRS） 和亚洲。这些站点将实施从I期安全试验到第三阶段的临床方案 功效试验，位于具有大量艾滋病毒的地区，人口适合 参加计划的预防和治疗临床试验。 MHRP的经验和 艾滋病毒疫苗研究的创新，并证明有能力解决新兴优先事项 艾滋病毒治疗研究将科学地为daids疫苗和治疗做出贡献 领导网络。 IAVI将贡献HIV预防和结核病疫苗科学 领导。扩展的MHRP CTU将带来daids，网络MHRP提出了 与国防部和IAVI的有价值的临床研究能力有隶属关系 支持员工。该提案的具体目的包括： 1。提供科学领导，新颖的产品和创新方法。 2。提供HIV疫苗临床试验网络和HIV的临床试验执行 预防临床试验网络科学议程。 3。提供HIV/AIDS成人治疗药物临床试验网络的临床试验执行 科学议程。