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DTG/3TC vs. BIC/FTC/TAF Maintenance Therapy in People Living With HIV:

NCT04884139 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 554

Last updated 2025-07-18

No results posted yet for this study

Summary

The hypothesize that DTG/3TC will be non-inferior to BIC/FTC/TAF with a 4% margin in virologically suppressed HIV-infected patients. The study will allow claiming for Superiority. Assuming that both DTG and BIC may lead to similar weight gains (approximately 1 kg after 48 weeks) in virologically suppressed HIV-infected patients and that TAF may induce a further weight gain (approximately 1 kg after 48 weeks), also hypothesize that switching to BIC/FTC/TAF may lead to greater weight gain than switching to DTG/3TC over 48 weeks.

This trial is a Phase IV, open-label, randomized multicentre clinical trial evaluating the efficacy of DTG/3TC versus BIC/FTC/TAF for the maintenance of virological suppression in HIV patients.

Conditions

Interventions

DRUG

Dolutegravir/Lamivudine as a single pill

\- Dose: Dolutegravir 50mg/ Lamivudine 300 mg -Route of adminstration: oral -Schedule of administration: once a day for 96 weeks.

DRUG

Bictegravir/Emtricitabine/Tenofovir alfenamide as a single pill.

* Dose: Bictegravir 50 mg/Emtricitabine 200 mg /Tenofovir alafenamide 25 mg * Route of adminstration: oral * Schedule of administration: once a day for 96 weeks.

Sponsors & Collaborators

  • ViiV Healthcare

    collaborator INDUSTRY

  • Fundacion SEIMC-GESIDA

    lead OTHER

Principal Investigators

  • Esteban Martinez, MD · H. Clinc de Barcelona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-14
Primary Completion
2024-02-20
Completion
2025-03-13

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04884139 on ClinicalTrials.gov