INNOVATE - Phase 2b Study Evaluating VH4524184 Regimens in Treatment Naïve Persons with HIV-1
Research type
Research Study
Full title
A Phase 2b Randomized, Open-Label Active Controlled Study Evaluating the Safety and Efficacy of Oral VH4524184 Coadministered with Emtricitabine and Tenofovir Alafenamide in Treatment Naïve Viremic Persons with HIV-1 (INNOVATE Study)
IRAS ID
1012780
Contact name
. .
Contact email
Sponsor organisation
ViiV Healthcare UK Limited
Eudract number
2025-521918-26
Research summary
The INNOVATE study is a clinical trial investigating a new treatment option for people living with Human immunodeficiency virus -1 (HIV-1) who have not previously received antiretroviral therapy (ART). HIV-1 is a virus that attacks the immune system, and lifelong treatment is required. Existing ART medicines work by stopping the virus from multiplying itself, which then reduces its presence in the body. In this study, the researchers want to see if the study medicine could be used to develop a future ART regimen that can be taken less often.
This study aims to explore whether VH4524184, taken with another approved medication called DESCOVY (a combination pill containing emtricitabine and tenofovir alafenamide, also known as FTC/TAF) is safe and effective in reducing HIV-1 levels compared to a commonly used treatment called DOVATO (dolutegravir and lamivudine combination pill, also known as DTG/3TC).
The study will involve approximately 150 adults globally, living with HIV-1. Participants will be randomly assigned to one of three groups: two groups will each receive a different dose of VH4524184, combined with DESCOVY, and the third group will receive DOVATO. Participants will be monitored over 24 months with regular clinic visits for health monitoring; blood tests to monitor HIV levels and immune response to treatment; safety assessments; and questionnaires about treatment satisfaction and quality of life. Visits occur monthly up until Month 10 and every two months thereafter. At Month 24, participants in the comparator arm receiving DOVATO will exit the study and participants receiving VH184 co-administered with DESCOVY will either exit the study or, if they are benefiting from treatment, may opt to enter a Continuation Period to continue receiving the study intervention and complete visits once every 3 months.
The study is sponsored by ViiV Healthcare, with support from GlaxoSmithKline (GSK).REC name
London - Riverside Research Ethics Committee
REC reference
26/LO/0031
Date of REC Opinion
14 Apr 2026
REC opinion
Further Information Favourable Opinion