A Study to Evaluate the Efficacy, Safety, and Tolerability of Using an Oral Once-daily 2 Drug Regimen Compared to an Oral Once-daily 3 Drug Regimen for the Treatment of Human Immunodeficiency Virus (HIV)-1 in Adults Who Have Not Previously Taken Antiretroviral Therapy (NCT05979311)
A Phase 3b, Multi-center, Randomized, Parallel-group, Open-label, Non-inferiority Study Evaluating the Efficacy, Safety, and Tolerability of Oral Dolutegravir/Lamivudine Once-daily as a First-line Regimen Compared to Oral Bictegravir/Emtricitabine/Tenofovir Alafenamide Once Daily for Virologic Suppression and Maintenance in Antiretroviral Therapy Naive Adults Living With HIV
🩺 Plain-English Summary (8th-Grade Level)
This study will compare safety, efficacy, participant reported outcomes and implementation outcomes of a fixed dose combination (FDC) of a two-drug regimen dolutegravir (DTG) plus lamivudine (3TC) and a three-drug regimen FDC of bictegravir (BIC), emtricitabine (FTC) and tenofovir alafenamide (TAF) in HIV-1 infected adult participants who have not previously received antiretroviral therapy.
Who can join: Review the eligibility criteria below.
Location: GSK Investigational Site — Ciudad Autonoma de Buenos Aire
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (64 Sites)
Showing the first 25 of 64 sites.
- GSK Investigational Site — Ciudad Autonoma de Buenos Aire,
- GSK Investigational Site — Córdoba,
- GSK Investigational Site — Antwerp,
- GSK Investigational Site — Brussels,
- GSK Investigational Site — Ghent,
- GSK Investigational Site — Hvidovre,
- GSK Investigational Site — Bordeaux,
- GSK Investigational Site — Bordeaux,
- GSK Investigational Site — Lyon,
- GSK Investigational Site — Montpellier,
- GSK Investigational Site — Nice,
- GSK Investigational Site — Nîmes,
- GSK Investigational Site — Paris,
- GSK Investigational Site — Paris,
- GSK Investigational Site — Paris,
- GSK Investigational Site — Paris,
- GSK Investigational Site — Berlin,
- GSK Investigational Site — Cologne,
- GSK Investigational Site — Frankfurt,
- GSK Investigational Site — Hamburg,
- GSK Investigational Site — München,
- GSK Investigational Site — Athens,
- GSK Investigational Site — Athens,
- GSK Investigational Site — Thessaloniki,
- GSK Investigational Site — Dublin,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.