United States Military HIV Research Program (MHRP) Clinical Trials Unit

美国军事艾滋病毒研究计划 (MHRP) 临床试验单位

• 批准号: 9186481
• 负责人: Nelson Lee Michael
• 金额: $ 141.03万
• 依托单位: WALTER REED ARMY INSTITUTE OF RESEARCH
• 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 2020-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9186481
• 关键词: AIDS clinical trial group; AIDS/HIV problem; Acquired Immunodeficiency Syndrome; Active Immunization; Acute; Address; Adult; Africa; Area; Asia; Cell Cycle; Clinical; Clinical Protocols; Clinical Research; Clinical Trials; Clinical Trials Network; Clinical Trials Unit; Cohort Studies; Communicable Diseases; Community Health; Comorbidity; Department of Defense; Development; Disease Progression; Funding; Future; Goals; HIV; HIV Infections; HIV vaccine; Hepatitis; Heterosexuals; Homosexuals; Immunity; Infection; International; Intervention; Kenya; Leadership; Maryland; Military Personnel; National Security; Passive Immunization; Pharmaceutical Preparations; Phase; Phase I Clinical Trials; Population; Prevention; Protein Subunits; Research; Research Activity; Research Infrastructure; Research Institute; Risk; Sampling Studies; Scourge; Site; Structure; Subunit Vaccines; Therapeutic; Therapeutic Clinical Trial; Therapeutic Human Experimentation; Therapeutic Trials; Tuberculosis; United States; Vaccine Research; Vaccines; Viral; Viral reservoir; Viremia; clinical research site; co-infection; combat; cost effective; efficacy trial; ethnic diversity; experience; immunogenicity; innovation; insight; novel; phase 1 study; prevent; programs; research and development; transmission process; vaccine trial; vector

DESCRIPTION (provided by the applicant): The Walter Reed Army Institute of Research (WRAIR) proposes 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 that supports the AIDS Clinical Trials Group at two sites to an additional five sites that will support the DAIDS Vaccine Trial Network. The MHRP CTU will comprise a core management group located at WRAIR in Maryland, United States and seven international Clinical Research Sites (CRS) located in Africa and Asia. These sites will conduct clinical protocols from phase I to phase III efficacy trials and are located in areas with substantial HIV burden and populations suitable to participate in planned vaccine and therapeutic clinical trials. MHRP's experience and innovation in HIV vaccine research and capability to address emerging priorities of HIV cure research will contribute scientifically to the DAIDS vaccine and therapeutics leadership networks. An expanded MHRP CTU will bring DAIDS-and the networks MHRP is proposing affiliation with-highly leveraged clinical research capacity with Department of Defense-supported staff and assets fully supported by Army funding. Specific aims of the proposal include: 1. To provide scientific expertise, development of novel products and innovative vaccine strategies and scientific approaches to contribute to both HIV vaccine development and therapeutic research. 2. To provide highly leveraged clinical trial execution of the DAIDS Vaccine network scientific agenda. 3. To provide highly leveraged clinical trial execution of the DAIDS Therapeutic trial network scientific agenda. RELEVANCE: HIV/AIDS is blunting or reversing indicators of community health. Reducing the toll of AIDS and other infectious diseases has been a goal of U.S. National Security Strategy since 2002. The crucible of efforts to combat the scourge of HIV/AIDS is clinical research leading to an effective HIV vaccine and treatments that cure or limit disease progression. The DAIDS Clinical Trials Network is the vital platform for this effort.

描述（由申请人提供）：沃尔特·里德陆军研究所 (WRAIR) 提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) 并使其多样化。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) 和其他机构的支持下开发的）来扩展当前由 DAIDS 资助的 CTU 活动，以支持艾滋病临床试验组两个地点到另外五个地点将支持 DAIDS 疫苗试验网络。 MHRP CTU 将由位于美国马里兰州 WRAIR 的核心管理团队和位于非洲和亚洲的七个国际临床研究中心 (CRS) 组成。这些地点将进行从第一阶段到第三阶段功效试验的临床方案，并且位于艾滋病毒负担重的地区和适合参加计划的疫苗和治疗临床试验的人群。 MHRP 在 HIV 疫苗研究方面的经验和创新以及解决 HIV 治疗研究新兴优先事项的能力将为 DAIDS 疫苗和治疗领导网络做出科学贡献。扩大后的 MHRP CTU 将带来 DAIDS（以及 MHRP 提议的附属网络），充分利用国防部支持的人员和资产的临床研究能力，并得到陆军资金的全面支持。 该提案的具体目标包括： 1. 提供科学专业知识、新产品开发以及创新疫苗策略和科学方法，为艾滋病毒疫苗开发和治疗研究做出贡献。 2. 为 DAIDS 疫苗网络科学议程提供高度有效的临床试验执行。 3. 为 DAIDS 治疗试验网络科学议程提供高度有效的临床试验执行。 相关性：艾滋病毒/艾滋病正在削弱或逆转社区健康指标。自 2002 年以来，减少艾滋病和其他传染病的死亡人数一直是美国国家安全战略的目标。抗击艾滋病毒/艾滋病祸害的关键是临床研究，以开发出有效的艾滋病毒疫苗和治愈或限制疾病进展的治疗方法。 DAIDS 临床试验网络是这项工作的重要平台。