RECRUITINGPhase 4INTERVENTIONAL

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

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).

Who May Be Eligible (Plain English)

Who May Qualify: - 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. - Willing to participate in the study. - Signed written willing to sign a consent form. - HIV-1 RNA \<50 copies/mL within 4 weeks prior to randomization. - eGFR by CKD-EPI ≥60 mL/min. Who Should NOT Join This Trial: - 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. - Diagnosis of malignancy prior to randomization. - Use of recreational drugs with anorexigenic potential (crystal meth, methamphetamines, cocaine) within 60 days prior to randomization. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * 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. * Willing to participate in the study. * Signed written informed consent. * HIV-1 RNA \<50 copies/mL within 4 weeks prior to randomization. * eGFR by CKD-EPI ≥60 mL/min. Exclusion Criteria: * 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. * Diagnosis of malignancy prior to randomization. * Use of recreational drugs with anorexigenic potential (crystal meth, methamphetamines, cocaine) within 60 days prior to randomization.

Treatments Being Tested

DRUG

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.

DRUG

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

Locations (1)

Hospital de Infectología, Centro Médico Nacional La Raza

Mexico City, Mexico City, Mexico