Clinical Research Directory
Browse clinical research sites, groups, and studies.
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
Sponsor: Instituto Mexicano del Seguro Social
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.
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
78
Start Date
2025-07-10
Completion Date
2026-12-10
Last Updated
2026-07-01
Healthy Volunteers
No
Interventions
Dual therapy: darunavir/cobicistat + lamivudine
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.
Triple therapy: darunavir/cobicistat plus tenofovir alafenamide/emtricitabine
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)
Hospital de Infectología "Dr Daniel Méndez Hernández" National Medical Center "La Raza", Instituto Mexicano del Seguro Social
Mexico City, Mexico City, Mexico