NCT07138144 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
| NCT ID | NCT07138144 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | José Antonio Mata Marín |
| Condition | HIV Infections |
| Study Type | INTERVENTIONAL |
| Enrollment | 156 participants |
| Start Date | 2025-07-12 |
| Primary Completion | 2026-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 156 participants in total. It began in 2025-07-12 with a primary completion date of 2026-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Frequently Asked Questions
Who can join the NCT07138144 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying HIV Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07138144 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07138144 currently recruiting?
Yes, NCT07138144 is actively recruiting participants. Visit ClinicalTrials.gov or contact José Antonio Mata Marín to inquire about joining.
Where is the NCT07138144 trial being conducted?
This trial is being conducted at Mexico City, Mexico.
Who is sponsoring the NCT07138144 clinical trial?
NCT07138144 is sponsored by José Antonio Mata Marín. The trial plans to enroll 156 participants.
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