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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

Study acronym: VOGUE
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment target: 473 to 307 Primary completion date changed from estimate of Mar 24, 2026 to Apr 15, 2026 · Start date: Feb 9, 2024 to Feb 21, 2024v6 Show 2 more changesShow less
    • Primary completion date changed from estimate of Mar 24, 2026 to Apr 15, 2026
    • Start date: Feb 9, 2024 to Feb 21, 2024
  2. Enrollment target: 481 to 473 Study sites: 65 to 64v5 Show 1 more changeShow less
    • Study sites: 65 to 64
  3. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 412 to confirmed 481 · Primary completion date: Nov 3, 2025 to Mar 24, 2026 · Completion date: Oct 5, 2026 to Feb 23, 2027 · 1 morev4 Show 4 more changesShow less
    • Enrollment target: estimated 412 to confirmed 481
    • Primary completion date: Nov 3, 2025 to Mar 24, 2026
    • Completion date: Oct 5, 2026 to Feb 23, 2027
    • Site details revised at 65 of 65 sites
  4. Trial status: Not Yet Recruiting to Recruiting Primary completion date: Sep 22, 2025 to Nov 3, 2025 · Completion date: Aug 24, 2026 to Oct 5, 2026 · Start date changed from estimate of Dec 29, 2023 to Feb 9, 2024 · 1 morev3 Show 4 more changesShow less
    • Primary completion date: Sep 22, 2025 to Nov 3, 2025
    • Completion date: Aug 24, 2026 to Oct 5, 2026
    • Start date changed from estimate of Dec 29, 2023 to Feb 9, 2024
    • Site details revised at 65 of 65 sites
  5. Start date: Nov 17, 2023 to Dec 29, 2023 Study sites: 0 to 65 · Primary completion date: Aug 11, 2025 to Sep 22, 2025 · Completion date: Jul 13, 2026 to Aug 24, 2026v2 Show 3 more changesShow less
    • Study sites: 0 to 65
    • Primary completion date: Aug 11, 2025 to Sep 22, 2025
    • Completion date: Jul 13, 2026 to Aug 24, 2026
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05979311
Lead Sponsor ViiV Healthcare
Conditions HIV, HIV Infections
Enrollment 307 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov