Phase II Clinical Trial to Reduce the Latent HIV-1 Reservoir Using High Doses of Antiretroviral Drugs Randomized Study Comparing Standard and Increased Doses of Dolutegravir, Maraviroc, and Lamivudine

What this Trial Is About

HIV-1 infection remains a significant global health challenge with social and economic impacts. While standard combination antiretroviral therapy TAR helps control the virus and improve quality of life, it does not fully address the viral reservoir that allows HIV to persist. This trial aims to study whether increasing antiretroviral drug levels in lymphatic tissue by administering higher doses can reduce or eliminate this latent HIV reservoir, potentially impacting long-term treatment and inflammation associated with HIV. Participants will be randomly assigned to one of two groups continuing their usual triple antiretroviral regimen containing an integrase inhibitor or receiving higher doses of three specific antiretroviral drugs dolutegravir 50 mg every 12 hours, maraviroc 300 mg every 12 hours, and lamivudine 300 mg every 12 hours. This study is open-label and controlled, planned to run for 48 weeks, to assess how increased drug levels affect viral replication and the latent reservoir. During the study, participants will undergo evaluations including measuring the size of the latent HIV reservoir in lymphoid tissue and blood, analyzing intracellular HIV RNA levels, immune activation markers, inflammation, and drug concentrations in blood and gastrointestinal tissue. Safety and tolerability of the higher dose regimen will also be monitored. Participants will be followed for 48 weeks to assess these outcomes and their overall health status.

Administration of High Doses of Antiretroviral Drugs to Eliminate the Latent HIV-1 Reservoir