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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexMale
Age18+
SponsorInstituto Mexicano del Seguro Social

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Withdrawal of informed consent

Loss of coverage

Failure to attend sample collection within the required timeframe

Trial design

Treatments tested in this trial

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

Treatment groups

78 Participants
are divided into 2 treatment groups