Clinical Trial

A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study)

Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
This clinical study is testing a new medication, VH4524184, to see if it can effectively treat HIV-1 in adults who have never received treatment for their infection. The study is comparing two different doses of VH4524184, each taken with the medications emtricitabine and tenofovir alafenamide (FTC/TAF), to a standard HIV treatment called dolutegravir and lamivudine (DTG/3TC). The purpose of the study is to provide data on the long-term antiviral activity of the VH4524184 and provide information regarding dosing formulation for further evaluations.
Protocol Amendment History 7 changes
notable Enrollment increased: 150 -> 186 participants 2026-07-24
notable Trial sites expanded: 113 -> 123 locations 2026-07-24
notable Primary completion moved earlier: 2027-07-26 -> 2027-06-11 2026-07-24
minor Completion moved earlier: 2028-07-24 -> 2028-05-22 2026-07-24
notable Trial sites expanded: 62 -> 113 locations 2026-05-09
notable Primary completion moved earlier: 2027-09-24 -> 2027-07-26 2026-05-09
minor Completion moved earlier: 2028-09-22 -> 2028-07-24 2026-05-09
Trial Details
NCT Number NCT07202546
Lead Sponsor ViiV Healthcare
Conditions HIV Infections
Enrollment 186 participants
Start Date 2026-02-11
Primary Completion 2027-06-11 (estimated)
Study Completion 2028-05-22 (estimated)
Updated on ClinicalTrials.gov 2026-07-23