150 Participants NeededMy employer runs this trial

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

Recruiting at 72 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: ViiV Healthcare
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

Inclusion Criteria

I haven't taken any HIV medications since my diagnosis.
I weigh at least 110 lbs if male, or 99 lbs if female, with a BMI of 18.5-35.5.
I am not able to have children or I am using highly effective birth control.
See 7 more

What Are the Treatments Tested in This Trial?

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Active Control

Group I: VH4524184 selected dose + FTC / TAFExperimental Treatment2 Interventions
Group II: VH4524184 Dose B + FTC / TAFExperimental Treatment2 Interventions
Group III: VH4524184 Dose A+ FTC / TAFExperimental Treatment2 Interventions
Group IV: DTG + 3TCActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

ViiV Healthcare

Lead Sponsor

Trials
379
Recruited
479,000+
Founded
2009
Headquarters
London, England, UK
Known For
HIV Research
Top Products
- Tivicay (dolutegravir), - Triumeq (abacavir/dolutegravir/lamivudine), - Juluca (dolutegravir/rilpivirine), - Apretude (cabotegravir)
Dr. Harmony Garges profile image

Dr. Harmony Garges

ViiV Healthcare

Chief Medical Officer

MD

Deborah Waterhouse profile image

Deborah Waterhouse

ViiV Healthcare

Chief Executive Officer since 2017

Bachelor's degree in Business Administration