Switching to a two-drug dolutegravir/lamivudine regimen versus staying on three-drug therapy for people with suppressed HIV

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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).

Why it matters

Who can join: the full rules

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 it's running

• Hospital de Infectología, Centro Médico Nacional La Raza
  Mexico City, Mexico City, Mexico Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.