A Randomized Comparison of Antiretroviral Therapy Alone Versus Antiretroviral Therapy with a'Kick-and-Kill'Approach, on Measures of the HIV Reservoir Amongst Participants with …

Background: Antiretroviral therapy (ART) alone cannot cure HIV infection because of a persistent reservoir of latently infected cells. Approaches that force HIV transcription from latently infected cells, making them susceptible to targeted killing-termed" kick and kill"-have the capacity to eliminate cells that comprise the reservoir, and have been explored as a strategy towards an HIV cure. RIVER is the first randomized trial to determine the impact of ART alone versus ART plus' kick-and-kill'on markers of the HIV reservoir.Methods: RIVER was an open-label, multicenter, 1: 1 randomized controlled trial of ART-only (control) versus ART plus the histone deacetylase inhibitor vorinostat (the'kick') and replication-deficient viral vector vaccines encoding conserved HIV sequences ChAdV63. HIVconsv-prime, MVA. HIVconsv-boost T-cell vaccination (the'kill')(ART+ V+ V; intervention) in HIV-positive adults treated in recent HIV-infection. The primary endpoint was total HIV DNA in peripheral blood CD4+ T-cells at weeks 16 and 18 post-randomization. Secondary endpoints included safety, quantitative viral outgrowth, HIV-specific T-cell frequencies, CD8+ T-cell mediated viral inhibition, and histone acetylation.