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
Sponsors and collaborators
José Antonio Mata Marín
Lead sponsor
Instituto Mexicano del Seguro Social
Sponsor institution