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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

NCT07138144

RecruitingPhase 4

Sponsor: José Antonio Mata Marín

Conditions: HIV Infections

Interventions: Standard Medical Therapy, dual therapy

Countries: Mexico

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 overview

Sex: ALL

Age: 18 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (1)

Mexico City, Mexico City, Mexico