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).
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.
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.
Parallel
Standard Medical Therapy
DrugIntervention arm will be dual therapy oh DTG 50 mg/ 3TC 300 mg, this will be compared to standar therapy of 3 drugs with: Bictegravir 50 mg / tenofovir alafenamide 25 mg / emtricitabine 200 mg or dolutegravir 50 mg / lamivudine 300 mg / abacavir 600 mg, both combinations in a single tablet.
dual therapy
DrugIntervention arm will be dual therapy oh DTG 50 mg/ 3TC 300 mg, this will be compared to standar therapy of 3 drugs
Effectiveness.
Effectiveness: Individuals with \>50 copies/ml.
Safety of switching ART regimen with an INSTI to DTG/3TC.
Number of participants with treatment-related adverse events as assessed of serious adverse events (WHO grade 3 or 4) for PWH treated with DTG/3TC at 24 and 48 weeks, expressed in proportions of new cases.
Tolerability of switching ART regimen with an INSTI to DTG/3TC.
Maintaining ART with DTG/3TC without changes, interruptions, or substitutions due to adverse effects or perceived discomfort.
Changes in lipid profile.
Changes in total cholesterol, HDL cholesterol, and triglycerides, measured in mg/dL.
Changes in body mass index
To evaluate changes in body mass index (BMI, kg/m²) at weeks 24 and 48.
Changes in waist circumference.
To evaluate changes greater than 90 cm in waist circumference at weeks 24 and 48.
Glucose metabolism disorders.
To determine changes at weeks 24 and 48, including the development of prediabetes or diabetes.
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José Antonio Mata Marín
Lead sponsor
Instituto Mexicano del Seguro Social
Sponsor institution
