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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

NCT07678268

RecruitingPhase 4

Sponsor: Instituto Mexicano del Seguro Social

Conditions: HIV Infection, Antiretroviral Therapy, Lentivirus Infections

Interventions: Dual therapy: darunavir/cobicistat + lamivudine, Triple therapy: darunavir/cobicistat plus tenofovir alafenamide/emtricitabine

Countries: Mexico

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 overview

Sex: MALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* Withdrawal of informed consent
* Loss of coverage
* Failure to attend sample collection within the required timeframe

Locations (1)

Mexico City, Mexico City, Mexico