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 | Recruiting Phase 4

• 1 other identifier: R-2025-3502-186
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

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).

Conditions

HIV Infections

Keywords

HIV; DTG/3TC; BIC/TAF/FTC; dual therapy; non-inferiority

Outcome Measures

Primary Outcomes (3)

• Effectiveness.

  Effectiveness: Individuals with \>50 copies/ml.

  24 and 48 weeks.

• Safety of switching ART regimen with an INSTI to DTG/3TC.

  Number of participants with treatment-related adverse events as assessed of serious adverse events (WHO grade 3 or 4) for PWH treated with DTG/3TC at 24 and 48 weeks, expressed in proportions of new cases.

  24 and 48 weeks.

• Tolerability of switching ART regimen with an INSTI to DTG/3TC.

  Maintaining ART with DTG/3TC without changes, interruptions, or substitutions due to adverse effects or perceived discomfort.

  24 and 48 weeks.

Secondary Outcomes (6)

• Changes in lipid profile.

  24 and 48 weeks

• Changes in body mass index

  24 and 48 weeks.

• Changes in waist circumference.

  24 and 48 weeks.

• Glucose metabolism disorders.

  24 and 48 weeks.

• Assess changes in blood pressure and cardiovascular risk

  24 and 48 weeks

Study Arms (2)

Standar therapy

ACTIVE COMPARATOR

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, will be used as standard therapy

Drug: Standard Medical Therapy

dual therapy

EXPERIMENTAL

This arm is the experimental one, with dual therapy, 2 drugs: Dolutegravir 50 mg/Lamivudina 300 mg, in a single tablet.

Drug: dual therapy

Interventions

Standard Medical Therapy DRUG

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.

Also known as: INSTI

Standar therapy

dual therapy DRUG

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

Also known as: DTG/3TC

dual therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• José Antonio Mata Marín: lead

Study Sites (1)

Hospital de Infectología, Centro Médico Nacional La Raza

Mexico City, Mexico City, 02990, Mexico

RECRUITING

Related Publications (4)

• MacPherson DW, Gushulak BD. Human mobility and population health. New approaches in a globalizing world. Perspect Biol Med. 2001 Summer;44(3):390-401. doi: 10.1353/pbm.2001.0053.

  PMID: 11482008 BACKGROUND

• Mann RB, Solodukhin SN. Conical geometry and quantum entropy of a charged Kerr black hole. Phys Rev D Part Fields. 1996 Sep 15;54(6):3932-3940. doi: 10.1103/physrevd.54.3932. No abstract available.

  PMID: 10021070 BACKGROUND

• Venkiteswaran K, Sgoutas DS, Santanam N, Neylan JF. Tacrolimus, cyclosporine and plasma lipoproteins in renal transplant recipients. Transpl Int. 2001 Dec;14(6):405-10. doi: 10.1007/s001470100006.

  PMID: 11793038 BACKGROUND

• van Wyk J, Ajana F, Bisshop F, De Wit S, Osiyemi O, Portilla Sogorb J, Routy JP, Wyen C, Ait-Khaled M, Nascimento MC, Pappa KA, Wang R, Wright J, Tenorio AR, Wynne B, Aboud M, Gartland MJ, Smith KY. Efficacy and Safety of Switching to Dolutegravir/Lamivudine Fixed-Dose 2-Drug Regimen vs Continuing a Tenofovir Alafenamide-Based 3- or 4-Drug Regimen for Maintenance of Virologic Suppression in Adults Living With Human Immunodeficiency Virus Type 1: Phase 3, Randomized, Noninferiority TANGO Study. Clin Infect Dis. 2020 Nov 5;71(8):1920-1929. doi: 10.1093/cid/ciz1243.

  PMID: 31905383 BACKGROUND

MeSH Terms

Conditions

HIV Infections

Interventions

Dual Anti-Platelet Therapy

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy, Combination; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Model Details: 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).

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 22, 2025
• Study Start: July 12, 2025
• Primary Completion: February 28, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)