drugset / Trial / NCT07202546

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

NCT07202546

Phase 2 Recruiting 150 enrolled ViiV Healthcare
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2026-02-11
Primary completion
2027-07-26
Completion
2028-07-24

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dolutegravir Other / unclassified Oral
Comparator Lamivudine Other / unclassified Oral
Subject VH4524184 Unknown Oral
Background emtricitabine Other / unclassified Oral
Background tenofovir alafenamide Small molecule Oral