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

Condition(s) studied

Investigational drug(s) / intervention(s)

Standard Medical Therapy: Intervention 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: Intervention arm will be dual therapy oh DTG 50 mg/ 3TC 300 mg, this will be compared to standar therapy of 3 drugs

Study summary

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

Primary outcome measure(s)

• Effectiveness. — 24 and 48 weeks.
  Effectiveness: Individuals with \>50 copies/ml.
• Safety of switching ART regimen with an INSTI to DTG/3TC. — 24 and 48 weeks.
  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. — 24 and 48 weeks.
  Maintaining ART with DTG/3TC without changes, interruptions, or substitutions due to adverse effects or perceived discomfort.

Trial sites (1)

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