Actively 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
Led by José Antonio Mata Marín · Updated on 2025-08-22
156
Participants Needed
1
Research Sites
54 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 design with follow-up assessments at 24 and 48 weeks. The study will enroll 156 PLWH aged ≥18 years who are on ART with BIC/FTC/TAF or DTG/3TC/ABC and have maintained virological suppression (HIV-1 RNA \<50 copies/mL) for at least 48 weeks. Participants will be randomized in a 2:1 ratio: 104 to switch to DTG/3TC and 52 to continue their current regimen (control group).
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- People living with HIV aged over 18 years
- Virologically suppressed (HIV-1 RNA <50 copies/mL) for at least 48 weeks before enrollment
- Currently 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 and able to provide signed informed consent
- Estimated glomerular filtration rate (eGFR) by CKD-EPI of 60 mL/min or higher
- HIV-1 RNA <50 copies/mL within 4 weeks prior to randomization
You will not qualify if you...
- Pregnant or breastfeeding patients
- Known allergies to any component of the antiretroviral regimens
- Coinfection with hepatitis B and/or hepatitis C virus
- Use of medications that interact with ART regimens
- Diagnosis of malignancy before randomization
- Use of recreational drugs with anorexigenic potential (crystal meth, methamphetamines, cocaine) within 60 days prior to randomization
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hospital de Infectología, Centro Médico Nacional La Raza
Mexico City, Mexico City, Mexico, 02990
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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