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
Recruiting
Phase 4
Interventional Study
HIV Infection
Antiretroviral Therapy
Lentivirus Infections
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Male
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 78 (estimated)
- Sponsor
- Instituto Mexicano del Seguro Social · Government
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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…
Trial Locations
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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 info…
Contacts