RecruitingPhase 1NCT07053384

A Study to Investigate the Use of VH3810109 With or Without Fostemsavir (FTR) to Reduce the Size and Activity of the Viral Reservoir in People Living With HIV

An Exploratory Phase 1b, Multicenter, Randomized, Open-Label Study to Investigate the Impact of the Administration of Intravenous VH3810109 With or Without Oral Fostemsavir in Combination With Integrase Inhibitor-Based Antiretroviral Therapy on the Viral Reservoir in Adults Living With HIV-1


Sponsor

ViiV Healthcare

Enrollment

100 participants

Start Date

Jul 10, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study investigates the use of VH3810109 with or without FTR to reduce the size and activity of the HIV viral reservoir in two sub-populations of people living with HIV: treatment-naïve adults (Population 1) and treatment-experienced adults currently taking a standard of care (SOC) integrase strand transfer inhibitor (INSTI)-based antiretroviral therapy (ART) regimen (Population 2).


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a new HIV treatment called VH3810109, alone or combined with an existing medication (fostemsavir), in people living with HIV who have developed resistance to many standard antiretroviral drugs. VH3810109 targets HIV in a new way, offering hope to people with very limited treatment options. **You may be eligible if...** - You are living with HIV and have developed resistance to multiple antiretroviral medications - You have very few remaining treatment options that can fully suppress your virus - Your current HIV medications are not keeping your viral load undetectable - You meet organ function and health requirements **You may NOT be eligible if...** - Your HIV is still well-controlled on your current regimen - You have certain other serious infections or illnesses - You have significant liver, kidney, or heart disease - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALVH3810109

VH3810109 will be administered.

DRUGFostemsavir (FTR)

Fostemsavir will be administered.

DRUGSOC INSTI-based ART

A SOC INSTI-based ART regimen will be administered.


Locations(41)

GSK Investigational Site

Chicago, Illinois, United States

GSK Investigational Site

New York, New York, United States

GSK Investigational Site

Bakersfield, California, United States

GSK Investigational Site

Ft. Pierce, Florida, United States

GSK Investigational Site

Orlando, Florida, United States

GSK Investigational Site

St Louis, Missouri, United States

GSK Investigational Site

Aarhus, Denmark

GSK Investigational Site

Barcelona, Spain

GSK Investigational Site

Hvidovre, Denmark

GSK Investigational Site

Rotterdam, Netherlands

GSK Investigational Site

Córdoba, Spain

GSK Investigational Site

La Laguna Santa Cruz, Spain

GSK Investigational Site

Pittsburgh, Pennsylvania, United States

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Kansas City, Missouri, United States

GSK Investigational Site

Dallas, Texas, United States

GSK Investigational Site

Brussels, Belgium

GSK Investigational Site

Cincinnati, Ohio, United States

GSK Investigational Site

Ghent, Belgium

GSK Investigational Site

Palma de Mallorca, Spain

GSK Investigational Site

Palma de Mallorca, Spain

GSK Investigational Site

London, United Kingdom

GSK Investigational Site

London, United Kingdom

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Seville, Spain

GSK Investigational Site

Valencia, Spain

GSK Investigational Site

Valencia, Spain

GSK Investigational Site

London, United Kingdom

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Dallas, Texas, United States

GSK Investigational Site

San Diego, California, United States

GSK Investigational Site

Philadelphia, Pennsylvania, United States

GSK Investigational Site

Barcelona, Spain

GSK Investigational Site

Barcelona, Spain

GSK Investigational Site

Barcelona, Spain

GSK Investigational Site

Barcelona, Spain

GSK Investigational Site

Barcelona, Spain

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NCT07053384


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