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

Unicenter, open-label, randomized, noninferiority trial included men with HIV-1 RNA levels \<50 copies/ml for at least 6 months on antiretroviral therapy with DRV/c + TFV/FTC (standar therapy), aged over 18 years. Participants were randomized to either continue standard therapy or switch to DRV/c+3TC. The primary end point was the proportion of subjects with HIV-1 RNA levels \>50 copies/ml after 48 weeks of follow-up according to the snapshot algorithm, with a non-inferiority margin of up to 10%. For statistical analysis, data distribution will be identified using the Kolmogorov-Smirnov test; categorical data will be analyzed using the X2 or Fisher test, as appropriate, and will be expressed as numbers and percentages. Quantitative data will be expressed as medians and interquartile ranges or means with standard deviations. A first analysis will be performed at 24 weeks, with follow-up at 48 weeks. The Student's t-test or the Mann-Whitney U-test will be used for data from independent groups according to their distribution.

NCT Number	NCT06907056
Lead Sponsor	José Antonio Mata Marín
Conditions	HIV Infection
Enrollment	138 participants
Start Date	2023-11-09
Primary Completion	2026-02-28 (estimated)
Study Completion	2026-11-30 (estimated)
Updated on ClinicalTrials.gov	2025-04-04