Comparison of DarunavirCobicistat Plus Lamivudine Versus DarunavirCobicistat Plus Tenofovir AlafenamideEmtricitabine for Virologically Suppressed Adult Men With HIV Evaluating Effectiveness and Safety at 24 and 48 Weeks

What this Trial Is About

Researchers are evaluating the effectiveness and safety of two drug regimens in adult men living with HIV who have maintained viral suppression for at least 48 weeks. This phase IV, open-label pilot trial compares dual therapy using darunavircobicistat plus lamivudine to triple therapy with darunavircobicistat plus tenofovir alafenamideemtricitabine. The study took place at a single center in Mexico City and aims to assess virological efficacy and safety at 24 weeks, with ongoing follow-up planned up to 48 and 96 weeks. Participants either continued their dual therapy regimen of darunavircobicistat 800150 mg with lamivudine 300 mg or switched from a triple therapy regimen including tenofovir disoproxil fumarateemtricitabine to tenofovir alafenamideemtricitabine 10200 mg while maintaining darunavircobicistat. The study involves non-randomized allocation and compares these two active treatment groups over the course of the trial. During the study, participants undergo regular laboratory tests including blood counts, chemistry panels, kidney and bone metabolism markers, CD4 cell counts, and HIV viral load measurements at baseline and weeks 4, 12, and 24. Adherence, treatment satisfaction, symptom burden, and neuropsychological status are assessed using questionnaires at multiple visits. Safety is closely monitored through physical exams and adverse event reporting. The main outcome measures include viral suppression rates and safety profiles at 24 and 48 weeks.

Effectiveness and Safety of Darunavir/Cobicistat Plus Lamivudine Compared With Darunavir/Cobicistat Plus Tenofovir Alafenamide/Emtricitabine in Virologically Suppressed People Living With HIV at 24 and 48 Weeks of Follow-up