Compares two HIV drug combinations in men whose virus is controlled
Tests two HIV drug combinations in adult men with suppressed virus.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Mexico City, MexicoSee the site
- Phase
- Phase 4
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for men living with HIV whose virus is well controlled on darunavir/cobicistat plus TDF/FTC. It compares two HIV treatment combinations.
- Age
- 18 years or older
- Sex
- Men only
- Disease stage
- HIV-1 infection with the virus kept under control for 48 weeks before the study.
- Earlier treatment
- At least 48 weeks on darunavir/cobicistat (800 mg/150 mg) plus TDF/FTC (300 mg/200 mg) before the study.
- Biomarker or test result
- Virus level kept under control for 48 weeks (HIV-1 RNA <50 copies/mL). Kidney function (eGFR by CKD-EPI) of 60 mL/min or more.
Main reasons for not taking part
- Withdrawal of informed consent
- Loss of coverage
- Failure to attend sample collection within the required timeframe
Read by machine on 9 November 2026.
Where in Mexico
- Hospital de Infectología "Dr Daniel Méndez Hernández" National Medical Center "La Raza", Instituto Mexicano del Seguro SocialMexico City, MexicoTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Instituto Mexicano del Seguro Social
- Trial code
- NCT07678268
- Record updated
- 1 July 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: Failure to attend sample collection within the required timeframe; Withdrawal of informed consent; Loss of coverage.