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
Instituto Mexicano del Seguro Social
78 participants
Jul 10, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Plain Language Summary
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This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
The 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.
The 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.
Locations(1)
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NCT07678268