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（Walter Reed）陆军研究所（WRAIR）提议扩展和多样化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 - 在美国陆军的支持下，艾滋病（DAIDS）和其他人的支持，以扩展当前由DAIDS资助的CTU活动，该活动支持艾滋病临床试验小组，该小组在两个地点，将支持五个地点，以支持DAIDS的其他五个地点 疫苗试验网络。 MHRP CTU将组成一个位于美国马里兰州沃尔的核心管理小组，以及位于非洲和亚洲的七个国际临床研究地点（CRS）。这些地点将进行从I期到第三阶段功效试验的临床方案，并位于具有大量HIV负担和种群的地区，适合于计划进行疫苗和治疗临床试验。 MHRP在HIV疫苗研究中的经验和创新能力以及解决艾滋病毒治疗研究的新兴优先级的能力将对daids疫苗和治疗剂领导力网络有科学贡献。扩大的MHRP CTU将带来daids，而网络MHRP提议与国防部支持的员工和资产在陆军资金中得到充分支持的杠杆临床研究能力。 该提案的具体目的包括： 1。提供科学专业知识，开发新产品和创新疫苗策略以及科学方法，以促进HIV疫苗开发和治疗研究。 2。提供高度杠杆的临床试验执行，销差疫苗网络科学议程。 3。提供高度杠杆的临床试验执行DAIDS治疗试验网络科学议程。 相关性：艾滋病毒/艾滋病正在使社区健康的指标变钝或逆转指标。自2002年以来，减少艾滋病和其他传染病的损失一直是美国国家安全战略的目标。抗击艾滋病毒/艾滋病祸害的努力是临床研究，导致有效的HIV疫苗和治疗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。