NCT07138144RecruitingPhase 4
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
Source: ClinicalTrials.gov · Last updated 22 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 156 (estimated)
- First submitted
- 4 Aug 2025
- Start date
- 12 Jul 2025
- Primary completion date
- 28 Feb 2026
- Lead sponsor
- José Antonio Mata Marín
- Diseases
- HIV
- NCT number
- NCT07138144
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 156
- From 12 Jul 2025 to the primary completion date, 28 Feb 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Known allergies to any component of the antiretroviral regimens.
- Coinfection with hepatitis B and/or hepatitis C virus.
Other
- Pregnant or breastfeeding patients.
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital de infectología, Centro Médico Nacional La Raza Coordinator of this site? Confirm its status | Mexico City | Mexico | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.