NCT07053384

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Conditions

• HIV Infections

Interventions

Type	Name	Description
BIOLOGICAL	VH3810109	VH3810109 will be administered.
DRUG	Fostemsavir (FTR)	Fostemsavir will be administered.
DRUG	SOC INSTI-based ART	A SOC INSTI-based ART regimen will be administered.

Timeline

• Start date: 2025-07-10
• Primary completion: 2027-01-22
• Completion: 2028-09-06
• First posted: 2025-07-08
• Last updated: 2026-03-24

Locations

41 sites across 6 countries: United States, Belgium, Denmark, Netherlands, Spain, United Kingdom

Regulatory

• FDA-regulated drug study