Status:
RECRUITING
Efficacy, Safety, and ToLerability of Switching to A Two-Drug Regimen With DTG/3TC Compared to Maintaining A Three-Drug REgimen With BIC/FTC/TAF or DTG/3TC/ABC in ViroLogically SupprEssed PeopLe Living With HIV After 24 and 48 Weeks of Follow-Up
Lead Sponsor:
José Antonio Mata Marín
Conditions:
HIV Infections
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
This is a phase 4, randomized, controlled, open-label, single-center clinical trial conducted at the Hospital de Infectología, National Medical Center "La Raza." The study employs a non-inferiority de...
Detailed Description
Since the identification of the human immunodeficiency virus (HIV), developing effective, safe, and well-tolerated antiretroviral therapy (ART) for people living with HIV (PLWH) has been a global heal...
Eligibility Criteria
Inclusion
- PLWH aged over 18 years.
- Virologically suppressed for at least 48 weeks prior to study enrollment.
- On ART with Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) or Dolutegravir/Lamivudine/Abacavir (DTG/3TC/ABC).
- No history of virologic failure.
- Willing to participate in the study.
- Signed written informed consent.
- HIV-1 RNA \<50 copies/mL within 4 weeks prior to randomization.
- eGFR by CKD-EPI ≥60 mL/min.
Exclusion
- Pregnant or breastfeeding patients.
- Known allergies to any component of the antiretroviral regimens.
- Coinfection with hepatitis B and/or hepatitis C virus.
- Concomitant medications that interact with any component of the ART regimens.
- Diagnosis of malignancy prior to randomization.
- Use of recreational drugs with anorexigenic potential (crystal meth, methamphetamines, cocaine) within 60 days prior to randomization.
Key Trial Info
Start Date :
July 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2026
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT07138144
Start Date
July 12 2025
End Date
July 30 2026
Last Update
August 22 2025
Active Locations (1)
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1
Hospital de Infectología, Centro Médico Nacional La Raza
Mexico City, Mexico City, Mexico, 02990