Tests switching to a two-drug HIV treatment in adults with controlled virus
Compares a two-drug HIV switch with staying on current treatment in adults.
Plain-language title generated from the registry record
Registry 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
Key facts
- Where
- Mexico City, MexicoSee the site
- Phase
- Phase 4
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults living with HIV whose virus is under control on a three-drug pill. Some will switch to a two-drug pill (DTG/3TC); others keep their current pill.
- Age
- Over 18 years, up to 70 years.
- Sex
- All sexes can join.
- Disease stage
- HIV-1 RNA below 50 copies/mL for at least 48 weeks, and again within 4 weeks before randomization. Kidney function (eGFR by CKD-EPI) of 60 mL/min or more.
- Earlier treatment
- Must be taking BIC/FTC/TAF or DTG/3TC/ABC. No past virologic failure.
- Biomarker or test result
- HIV-1 RNA below 50 copies/mL. eGFR by CKD-EPI 60 mL/min or more.
Main reasons for not taking part
- Pregnant or breastfeeding
- Known allergy to any part of the antiretroviral regimens
- Hepatitis B and/or hepatitis C coinfection
- Taking medicines that interact with the regimens
- Cancer diagnosed before randomization
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT07138144, who can take part
Where in Mexico
- Hospital de infectología, Centro Médico Nacional La RazaMexico City, MexicoTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- José Antonio Mata Marín
- Trial code
- NCT07138144
- Record updated
- 22 August 2025
- Original description
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).Read full original descriptionShow less
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
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).
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: 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; Known allergies to any component of the antiretroviral regimens; Coinfection with hepatitis B and/or hepatitis C virus; Pregnant or breastfeeding patients.