RecruitingPhase 4NCT07138144

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

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

Sponsor

José Antonio Mata Marín

Enrollment

156 participants

Start Date

Jul 12, 2025

Study Type

INTERVENTIONAL

Conditions

HIV Infections

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

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing a two-drug HIV treatment regimen (dolutegravir + lamivudine, also known as Dovato) to a three-drug regimen in people living with HIV who already have an undetectable viral load. The goal is to see if simplifying treatment to two drugs maintains virus suppression just as well with potentially fewer side effects. **You may be eligible if...** - You are over 18 years old and living with HIV - Your HIV has been undetectable (viral load under 50 copies/mL) for at least 48 weeks - You are currently taking either BIC/FTC/TAF (Biktarvy) or DTG/3TC/ABC (Triumeq) - You have no history of HIV treatment failure - Your kidney function is adequate **You may NOT be eligible if...** - You are pregnant or breastfeeding - You also have hepatitis B or C infection - You have a history of cancer - You are taking medications that interact with the study drugs - You use recreational drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGStandard 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.

DRUGdual therapy

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