Darunavir/ritonavir plus lamivudine vs darunavir/ritonavir plus tenofovir alafenamide/emtricitabine in virologically suppressed adults with HIV
Official 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
Run by Instituto Mexicano del Seguro Social · NCT07678268 · Data updated 2026-11-12
This trial tests whether a two-drug regimen (darunavir/cobicistat plus lamivudine) works as well as a three-drug regimen (darunavir/cobicistat plus TAF/FTC) in adults with HIV who have stable viral suppression.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | Men only |
| Enrollment | 78 (estimated) |
| Sponsor | Instituto Mexicano del Seguro Social Government |
| Locations | 1 site (Mexico City, Mexico City) |
| Status | Recruiting |
| Started | July 10, 2025 |
| Main results expected | July 10, 2026 |
| Study ends | December 10, 2026 |
| Registry record updated | July 1, 2026 |
| Trial ID | NCT07678268 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adult men (≥18 years) living with HIV who have virologic suppression for 48 weeks on DRV/c + 3TC or DRV/c + TDF/FTC and have eGFR ≥60 mL/min/1.73 m².
✕Probably not a fit
Patients with prior virological failure, resistance mutations to study drugs, active cancer, HBV or HCV coinfection, or poor adherence may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a phase IV, open-label pilot study conducted at a single center in Mexico City. Adults living with HIV who have maintained viral suppression for at least 48 weeks on a DRV/c plus lamivudine or a DRV/c plus TDF/FTC regimen are switched or continued on either the two-drug or the three-drug regimen. The primary endpoints are virological efficacy and safety at 24 weeks, with follow-up to 48 weeks. The study assesses renal safety and neuropsychiatric adverse events among other safety signals. Enrollment is non-randomized and participants remain under standard HIV care at the La Raza hospital, IMSS.
Why it matters
Potential benefit: If successful, the two-drug regimen could reduce pill burden and potential drug exposure while maintaining viral suppression and safety.
How similar studies have gone: Prior two-drug regimens have shown mixed but promising results in various settings; this pilot adds data in a specialized population and is not yet definitive.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Hospital de Infectología "Dr Daniel Méndez Hernández" National Medical Center "La Raza", Instituto Mexicano del Seguro Social
Mexico City, Mexico City, Mexico Recruiting
Study contacts
- Principal investigator: Sandra Patricia Ramírez Eguia — Instituto Mexicano del Seguro Social
- Study coordinator: José Antonio Mata Marín, Master
- Email: sandrarmzeg@gmail.com
- Phone: +524428518215
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.