NCT07678268RecruitingPhase 4
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
Source: ClinicalTrials.gov · Last updated 1 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 78 (estimated)
- First submitted
- 25 Jun 2026
- Start date
- 10 Jul 2025
- Primary completion date
- 10 Jul 2026
- Lead sponsor
- Instituto Mexicano del Seguro Social
- Diseases
- HIV
- NCT number
- NCT07678268
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 78
- From 10 Jul 2025 to the primary completion date, 10 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Failure to attend sample collection within the required timeframe
Other
- Withdrawal of informed consent
- Loss of coverage
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital de Infectología "Dr Daniel Méndez Hernández" National Medical Center "La Raza", Instituto Mexicano del Seguro Social Coordinator of this site? Confirm its status | Mexico City | Mexico | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.