Clinical Trial

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
Active, Not Recruiting Phase 3
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Summary
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.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2023-08-04; most recent amendment 2026-06-29.
Status change: Recruiting → Active, Not Recruiting 2025-05-26
Status change: Not Yet Recruiting → Recruiting 2024-08-15
Trial Details
NCT Number NCT05979311
Lead Sponsor ViiV Healthcare
Conditions HIV, HIV Infections
Enrollment 307 participants
Start Date 2024-02-21
Primary Completion 2026-04-15 (estimated)
Study Completion 2027-02-23 (estimated)
Updated on ClinicalTrials.gov 2026-07-02