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
Recruiting · NCT07678268 · Interventional (participants receive a specific treatment) · Lead sponsor: Instituto Mexicano del Seguro Social
View the official record on ClinicalTrials.gov →Interventions studied
Dual therapy: darunavir/cobicistat + lamivudineTriple therapy: darunavir/cobicistat plus tenofovir alafenamide/emtricitabine
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed.
- Hospital de Infectología "Dr Daniel Méndez Hernández" National Medical Center "La Raza", Instituto Mexicano del Seguro Social - Mexico City, Mexico City, Mexico