NCT07678268 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
| NCT ID | NCT07678268 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Instituto Mexicano del Seguro Social |
| Condition | HIV Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 78 participants |
| Start Date | 2025-07-10 |
| Primary Completion | 2026-07-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 78 participants in total. It began in 2025-07-10 with a primary completion date of 2026-07-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Sandra Patricia Ramírez Eguia
PRINCIPAL INVESTIGATOR
Instituto Mexicano del Seguro Social
Frequently Asked Questions
Who can join the NCT07678268 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying HIV Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07678268 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07678268 currently recruiting?
Yes, NCT07678268 is actively recruiting participants. Contact the research team at sandrarmzeg@gmail.com for enrollment information.
Where is the NCT07678268 trial being conducted?
This trial is being conducted at Mexico City, Mexico.
Who is sponsoring the NCT07678268 clinical trial?
NCT07678268 is sponsored by Instituto Mexicano del Seguro Social. The principal investigator is Sandra Patricia Ramírez Eguia at Instituto Mexicano del Seguro Social. The trial plans to enroll 78 participants.
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