VOGUE:Phase3b study comparing 2 oral regimens in naive adults with HIV
Research type
Research Study
Full title
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
IRAS ID
1008586
Contact name
Karen Grainger
Contact email
Sponsor organisation
ViiV Healthcare UK Limited
Clinicaltrials.gov Identifier
Research summary
Human immunodeficiency virus (HIV) damages the body’s defence system and weakens the ability to fight infections. Timely treatment after initial HIV diagnosis is critical to successful HIV treatment. However, people presenting late for treatment are at an increased risk of occurrence of an immune reconstitution syndrome (worsening of pre-existing infection in the setting of improved immune system) and other complications following initiation of antiretroviral therapy (ART).
The purpose of the study is to compare the efficacy, safety, patient reported and implementation outcomes of treatment with dolutegravir plus lamivudine (DTG/3TC) to that of bictegravir, emtricitabine and tenofovir alafenamide (BIC/FTC/TAF), each given once daily in people with HIV who had never received treatment (ART-naïve) for their HIV infection before.
All participants enrolled in the study will either receive DTG/3TC or BIC/FTC/TAF orally (by mouth) once a day.
Participants will be in the study for about 2 years and will have regular medical tests and assessments performed (including blood tests, questionnaires, and interviews).
Participants who complete the study at Week 96 will transition off the study to locally accessible Dovato or Biktarvy, or to an alternative local standard of care HIV treatment as agreed between the participant and the study doctor.REC name
London - Central Research Ethics Committee
REC reference
23/LO/0830
Date of REC Opinion
7 Nov 2023
REC opinion
Further Information Favourable Opinion