(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.

Public Health 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.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Project with Complex Structure Cooperative Agreement (UM1)
Project #
1UM1AI108568-01
Application #
8609674
Study Section
Special Emphasis Panel (ZAI1-BP-A (S3))
Program Officer
Potter, Dara G
Project Start
2013-12-10
Project End
2020-11-30
Budget Start
2013-12-10
Budget End
2014-11-30
Support Year
1
Fiscal Year
2014
Total Cost
$1,277,995
Indirect Cost
Name
U.S. Walter Reed Army Institute of Research
Department
Type
DUNS #
129615428
City
Silver Spring
State
MD
Country
United States
Zip Code
20910