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
Recruiting · NCT07138144 · Interventional (participants receive a specific treatment) · Lead sponsor: José Antonio Mata Marín
View the official record on ClinicalTrials.gov →Interventions studied
Standard Medical Therapydual therapy
What this trial is about
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 can take part
Age range
18 Years to 70 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- Hospital de Infectología, Centro Médico Nacional La Raza - Mexico City, Mexico City, Mexico