NCT06214052

VH4524184 Proof-of-Concept in Treatment-Naïve Adults Living With HIV-1

A Phase 2a, Randomized, Double-Blind (Sponsor Unblinded), Placebo-Controlled, Study to Investigate the Antiviral Effect, Safety, Tolerability and Pharmacokinetics of VH4524184 in HIV-1 Infected Treatment Naïve Adults

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety, tolerability, ability of VH4524184 when given alone to reduce the amount of HIV (viral load) in people with HIV-1 infection who have never received antiretroviral therapy (treatment-naïve). Data from this study will be used to decide how VH4524184 can be best included in a full-treatment regimen for HIV-1 in the future.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	VH4524184	VH4524184 was administered as tablets orally at Day 1.
DRUG	Matching Placebo	VH4524184 Matching Placebo was administered as tablets orally at Day 1.
DRUG	Antiretroviral therapy	Antiretroviral therapy was administered as available and as per investigator's recommendation.

Timeline

• Start date: 2024-02-07
• Primary completion: 2024-06-12
• Completion: 2024-06-12
• First posted: 2024-01-19
• Last updated: 2025-06-29
• Results posted: 2025-06-29

Locations

17 sites across 5 countries: United States, Argentina, Canada, Italy, Spain

Regulatory

• FDA-regulated drug study