Comparing DarunavirCobicistat Plus Lamivudine to DarunavirCobicistat Plus TenofovirEmtricitabine for Men with Controlled HIV-1 Infection in Mexico 48-Week Safety and Effectiveness Study

What this Trial Is About

This research evaluates the effectiveness, safety, and tolerability of two antiretroviral therapies in men living with HIV who have had undetectable HIV-1 RNA levels for at least 6 months. Specifically, the study compares the standard three-drug therapy using darunavircobicistat plus tenofoviremtricitabine with an experimental dual therapy of darunavircobicistat plus lamivudine. The trial is open-label, randomized, and focuses on whether the dual therapy is not less effective than standard therapy over 48 weeks. Participants are randomly assigned to either continue the standard treatment of darunavircobicistat 800 mg150 mg plus tenofoviremtricitabine 300 mg200 mg once daily or switch to the dual therapy of darunavircobicistat 800 mg150 mg plus lamivudine 300 mg once daily. The study includes an initial analysis at 24 weeks and continued follow-up at 48 weeks. Various laboratory tests, body composition measurements, and questionnaires assessing mental health and treatment satisfaction are conducted throughout the study. During participation, men will have regular medical visits with laboratory assessments including blood counts, liver function, kidney function, lipid profiles, and viral load measurements before randomization and at 3, 6, and 12 months afterward. Questionnaires evaluating anxiety, depression, sleep quality, and treatment satisfaction are also administered. Researchers will monitor adverse effects and classify them according to severity. The primary outcome is the proportion of participants maintaining viral suppression, measured at 48 weeks, with safety and tolerability also evaluated.

Effectiveness and Safety of Darunavir/Cobicistat Plus Lamivudine Versus Darunavir/Cobicistat Plus Tenofovir/Emtricitabine in Virologically Suppressed HIV-1-positive Individuals in Mexico