NCT07202546

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

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 Naive Viremic Persons With HIV-1 (INNOVATE Study)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	VH4524184	Oral tablet will be administered.
DRUG	Emtricitabine (FTC) and tenofovir alafenamide (TAF) Fixed Dose Combination (FDC) tablets	Oral table will be administered.
DRUG	Dolutegravir / Lamivudine (DTG/3TC)	Oral tablets will be administered.

Timeline

• Start date: 2026-02-11
• Primary completion: 2027-09-24
• Completion: 2028-09-22
• First posted: 2025-10-02
• Last updated: 2026-03-12

Locations

62 sites across 6 countries: United States, Argentina, Canada, Japan, Spain, Taiwan

Regulatory

• FDA-regulated drug study