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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

RecruitingPhase 4Ages 18 Years - 70 YearsAllJosé Antonio Mata Marín
NCT07138144 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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).

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📋 Eligibility rules (as published)
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.
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What it tests

  • Standard Medical Therapy
  • dual therapy
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Where

1 site
Hospital de Infectología, Centro Médico Nacional La Raza
Mexico City, Mexico
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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