Switching to a two-drug dolutegravir/lamivudine regimen versus staying on three-drug therapy for people with suppressed HIV
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 trial will test whether switching to a two-drug regimen (dolutegravir/lamivudine) keeps viral suppression and reduces metabolic and tolerability problems in adults with HIV who are already virologically suppressed on three-drug therapy.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 156 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Instituto Mexicano del Seguro Social Government |
| Locations | 1 site (Mexico City, Mexico City) |
| Trial ID | NCT07138144 on ClinicalTrials.gov |
What this trial studies
This is a phase 4, randomized, open-label, single-center non-inferiority trial enrolling 156 adults with HIV who have maintained viral suppression for at least 48 weeks. Participants on BIC/FTC/TAF or DTG/3TC/ABC are randomized 2:1 to switch to DTG/3TC or to continue their current three-drug regimen, with follow-up visits at 24 and 48 weeks. Primary outcomes focus on maintaining virological suppression, while secondary outcomes include changes in lipid profile, BMI, abdominal circumference, glucose metabolism, and blood pressure. The trial excludes people with hepatitis B/C coinfection, recent substance use with anorexigenic potential, pregnancy or breastfeeding, significant drug interactions, prior virologic failure, or reduced renal function (eGFR <60 mL/min).
Who should consider this trial
Good fit: Adults (≥18 years) with HIV who have been virologically suppressed (HIV-1 RNA <50 copies/mL) for at least 48 weeks on BIC/FTC/TAF or DTG/3TC/ABC, have eGFR ≥60 mL/min, no hepatitis B/C coinfection, and are willing to attend visits at the study site are ideal candidates.
Not a fit: People with hepatitis B coinfection, prior virologic failure, pregnancy or breastfeeding, interacting concomitant medications, recent use of certain recreational drugs, or significant renal impairment are unlikely to benefit or are ineligible for this switch approach.
Why it matters
Potential benefit: If successful, switching to DTG/3TC could maintain viral suppression while lowering pill burden and decreasing metabolic and tolerability-related side effects.
How similar studies have performed: Previous randomized trials such as GEMINI, TANGO, SALSA and others have shown that dolutegravir/lamivudine two-drug regimens can provide comparable virological efficacy and improved tolerability in selected patients.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Mexico City, Mexico City
- Hospital de Infectología, Centro Médico Nacional La Raza — Mexico City, Mexico City, Mexico (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.