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
A single-center, open-label, randomized pilot clinical trial between March 2025 and March 2026 at the Hospital de Infectología La Raza National Medical Center in Mexico City. Eligible participants were adult males (≥18 years) with HIV-1 infection who had maintained virological suppression (HIV-1 RNA \<50 copies/mL) for 48 weeks on either DRV/c + 3TC or DRV/c + TDF/FTC prior to enrollment (TLALOC-1 trial), and had an estimated glomerular filtration rate (eGFR) by CKD-EPI ≥60 mL/min/1.73 m². The primary endpoints were virological efficacy and safety at 24 weeks.
• Virologically suppressed men living with HIV, transitioning from a DRV/c (800 mg/150 mg) + TDF/FTC (300 mg/200 mg) regimen for at least 48 weeks prior to the study
• Viral suppression for 48 weeks prior to the study
• Agree to participate in the study by signing a written informed consent form
• Age ≥18 years
• Glomerular filtration rate (GFR) by CDK-EPI ≥60 mL/min
• Beneficiaries of the Mexican Social Security Institute (IMSS) treated at the Infectious Diseases Hospital of the La Raza National Medical Center