: 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.
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.
|Hosseinipour, Mina C; Kang, Minhee; Krown, Susan E et al. (2018) As-Needed Vs Immediate Etoposide Chemotherapy in Combination With Antiretroviral Therapy for Mild-to-Moderate AIDS-Associated Kaposi Sarcoma in Resource-Limited Settings: A5264/AMC-067 Randomized Clinical Trial. Clin Infect Dis 67:251-260|
|Sattler, Fred R; Chelliah, Daniel; Wu, Xingye et al. (2018) Biomarkers Associated with Death After Initiating Treatment for Tuberculosis and HIV in Patients with Very Low CD4 Cells. Pathog Immun 3:46-62|
|Ngongondo, McNeil; Miyahara, Sachiko; Hughes, Michael D et al. (2018) Hepatotoxicity During Isoniazid Preventive Therapy and Antiretroviral Therapy in People Living With HIV With Severe Immunosuppression: A Secondary Analysis of a Multi-Country Open-Label Randomized Controlled Clinical Trial. J Acquir Immune Defic Syndr 78:54-61|
|Bisson, Gregory P; Ramchandani, Ritesh; Miyahara, Sachiko et al. (2017) Risk factors for early mortality on antiretroviral therapy in advanced HIV-infected adults. AIDS 31:2217-2225|
|Mukherjee, Pranab K; Chen, Huichao; Patton, Lauren L et al. (2017) Topical gentian violet compared with nystatin oral suspension for the treatment of oropharyngeal candidiasis in HIV-1-infected participants. AIDS 31:81-88|
|Hosseinipour, Mina C; Bisson, Gregory P; Miyahara, Sachiko et al. (2016) Empirical tuberculosis therapy versus isoniazid in adult outpatients with advanced HIV initiating antiretroviral therapy (REMEMBER): a multicountry open-label randomised controlled trial. Lancet 387:1198-209|
|La Rosa, Alberto M; Harrison, Linda J; Taiwo, Babafemi et al. (2016) Raltegravir in second-line antiretroviral therapy in resource-limited settings (SELECT): a randomised, phase 3, non-inferiority study. Lancet HIV 3:e247-58|
|Shaffer, Douglas; Hughes, Michael D; Sawe, Fredrick et al. (2014) Cardiovascular disease risk factors in HIV-infected women after initiation of lopinavir/ritonavir- and nevirapine-based antiretroviral therapy in Sub-Saharan Africa: A5208 (OCTANE). J Acquir Immune Defic Syndr 66:155-63|
|Mwafongo, Albert; Nkanaunena, Kondwani; Zheng, Yu et al. (2014) Renal events among women treated with tenofovir/emtricitabine in combination with either lopinavir/ritonavir or nevirapine. AIDS 28:1135-42|
|Asmelash, Aida; Zheng, Yu; Kaloustian, Kara Wools et al. (2014) Predictors of suboptimal CD4 response among women achieving virologic suppression in a randomized antiretroviral treatment trial, Africa. BMC Infect Dis 14:331|
Showing the most recent 10 out of 11 publications