Clinical Trial

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

Study acronym: TLACAELEL
Recruiting Phase 4
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Record status
This record was last updated August 22, 2025 (before its estimated February 28, 2026 completion). Its status may not reflect the trial's current state.
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).
Trial Details
NCT Number NCT07138144
Lead Sponsor José Antonio Mata Marín
Conditions HIV Infections
Enrollment 156 participants
Start Date 2025-07-12
Primary Completion 2026-02-28 (estimated)
Study Completion 2026-07-30 (estimated)
Updated on ClinicalTrials.gov 2025-08-22