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
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
José Antonio Mata Marín
156 participants
Jul 12, 2025
INTERVENTIONAL
Conditions
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 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).
Eligibility
Inclusion Criteria8
- 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 Criteria6
- 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.
Interventions
Intervention arm will be dual therapy oh DTG 50 mg/ 3TC 300 mg, this will be compared to standar therapy of 3 drugs with: Bictegravir 50 mg / tenofovir alafenamide 25 mg / emtricitabine 200 mg or dolutegravir 50 mg / lamivudine 300 mg / abacavir 600 mg, both combinations in a single tablet.
Intervention arm will be dual therapy oh DTG 50 mg/ 3TC 300 mg, this will be compared to standar therapy of 3 drugs
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07138144