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
Withdrawal of informed consent
Loss of coverage
Failure to attend sample collection within the required timeframe
Parallel
Dual therapy: darunavir/cobicistat + lamivudine
DrugThe intervention group will receive dual therapy with DRV/C 800/150 mg + 3TC 300 mg, which will be compared to standard 3-drug therapy: DRV/C 800/150 mg + TAF/FTC 10/200 mg.
Triple therapy: darunavir/cobicistat plus tenofovir alafenamide/emtricitabine
DrugThe intervention group will receive triple therapy: DRV/C 800/150 mg + TAF/FTC 10/200 mg.which will be compared to dual therapy with DRV/C 800/150 mg + 3TC 300 mg.
Effectiveness
HIV-1 RNA ≥50 copies/mL
To determine the safety and tolerability of darunavir/cobicistat plus lamivudine compared with darunavir/cobicistat plus tenofovir alafenamide/emtricitabine in virologically suppressed people living with HIV
Safety was monitored at every visit through direct questioning and clinical evaluation, categorized by organ system according to DAIDS criteria Division of AIDS Drug-Associated Adverse Event Severity Scale (DAIDS), which classifies them on a scale of 1 to 4. Grade 1: Mild or no harm; Grade 2: Moderate adverse events or minimal interference with social and functional activities; Grade 3: Severe symptoms causing inability to perform social/functional activities or requiring hospitalization; Grade IV: Life-threatening events with symptoms causing inability to perform basic self-care and where intervention is required to prevent permanent deterioration or death.
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