MHRP is a broad-based, highly collaborative, and highly integrated research program with strong epidemiology, preclinical and clinical research capabilities.
MHRP is actively engaged in therapeutic studies to ensure optimal HIV care and treatment services are provided.
AIDS Clinical Trials Group (ACTG)
Immune Reconstitution Inflammation Syndrome (IRIS)
CLinic-based ART Diagnostic Evaluation (CLADE)
The U.S. Military HIV Research Program continues to expand therapeutics research activities through a diversified portfolio and partnerships with:
Our recent growth in therapeutics research is due in large part to MHRP becoming an AIDS Clinical Trial Group (ACTG) Clinical Trials Unit (CTU) in 2009. Our researchers are currently working with the ACTG to plan studies looking at HIV-malaria co-infection. This collaboration draws on the military’s experience and expertise in malaria research, which has been ongoing in Africa for more than 40 years.
We currently have two Clinical Research Sites (CRSs) in Kenya—Eldoret and Kericho. Current therapeutic studies conducted with the ACTG include the OCTANE and STRIDE studies:
OCTANE - Optimal Combination Therapy After Nevirapine Exposure
With early results demonstrating the superiority of protease-inhibitor-based antiretroviral therapy (ART) compared to nevirapine-based ART in women who had single-dose nevirapine in the context of Prevention of Mother to Child Transmission (PMTCT) of HIV, OCTANE provides definitive randomized controlled trial data that will guide PMTCT policy and practices throughout Sub-Saharan Africa.
STRIDE - MHRP partnered with the ACTG in conducting a study evaluating when best to start ART in persons with both HIV and tuberculosis (TB) who have started TB therapy. These results may help guide policy for treating HIV and TB co-infections in Africa.
Future ACTG Studies
Future studies anticipated at the MHRP CRSs include evaluating optimal treatments for cryptococcal meningitis as well as Kaposi’s Sarcoma. Finally, the MHRP in partnership with ACTG is working to develop clinical trials evaluating optimal treatments of the HIV-malaria co-infection, a priority activity of the ACTG.
A Cohort Observational Study Evaluating Predictors, Incidence, Clinical Presentation and Immunopathogenesis of Immune Reconstitution Inflammation Syndrome (IRIS) in HIV-1 Infected Patients with CD4 Count < 100 Cells/µL Who Are Initiating Antiretroviral Therapy
MHRP continues to conduct the “IRIS” study, which was the first Infectious Disease Clinical Research Program (IDCRP) HIV trial to open in Africa.
The IRIS study evaluates HIV-1 infected patients with advanced AIDS who are starting ART. IRIS is a clinical syndrome that has been described in HIV-infected patients after initiation of highly active antiretroviral therapy (HAART) and is characterized by paradoxical acute worsening of an underlying opportunistic infection or AIDS-defining illness. Conducted in collaboration with NIAID, this study will provide details regarding the immunopathogenesis of IRIS with advanced laboratory studies simultaneously being conducted at NIH and Kericho.
CLinic-based ART Diagnostic Evaluation
CLADE is MHRP’s first prospective public health evaluation funded by PEPFAR. It is an unblinded, randomized prospective, observational, cohort public health evaluation aimed at determining the superiority and cost-effectiveness of two recommended Ministry of Health ART diagnostic evaluation approaches: routine care and viral load guided care. CLADE is unique in that it addresses critical monitoring questions at the actual clinic level and includes actual costs for cost-effectiveness evaluations as a primary study objective.
Our dedicated researchers and support staff are working to stop the spread of HIV/AIDS around the world.
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