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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-70
SponsorJosé Antonio Mata Marín

About this trial

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).

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Standard Medical Therapy
  • dual therapy

Treatment groups

156 Participants
are divided into 2 treatment groups

Sponsors and collaborators

José Antonio Mata Marín

Lead sponsor

Instituto Mexicano del Seguro Social

Sponsor institution