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

Sex: Male

Ages: 18 Years – N/A

Healthy volunteers: No

Phase: PHASE4

Enrollment: 78

Sponsor: Instituto Mexicano del Seguro Social

Location: Hospital de Infectología "Dr Daniel Méndez Hernández" National Medical Center "La Raza", Instituto Mexicano del Seguro Social Mexico City Mexico City

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 \

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07678268). StuddyBuddy aggregates publicly available trial information.