NCT06039579

Proof of Concept Treatment Study of Orally Administered VH4004280 or VH4011499 in HIV-1 Infected Adults

A Randomized, Double-Blind (Sponsor Unblinded), Placebo-Controlled, Phase 2a Trial to Investigate the Antiviral Effect, Safety, Tolerability and Pharmacokinetics of Orally Administered Investigational Capsid Inhibitor Monotherapy in HIV-1 Infected Treatment-Naïve Adults

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of the study is to evaluate the antiviral activity of orally administered VH4004280 and VH4011499 monotherapy over 10 days in human immunodeficiency virus (HIV-1) infected Treatment-Naïve (TN) participants.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	VH4004280	VH4004280 was administered as tablets orally at Day 1.
DRUG	VH4011499	VH4011499 was administered as tablets orally at Day 1 and Day 6.
DRUG	VH4004280 Matching Placebo	VH4004280 Matching Placebo was administered as tablets orally at Day 1.
DRUG	VH4011499 Matching Placebo	VH4011499 Matching Placebo was administered as tablets orally at Day 1 and Day 6.
DRUG	Antiretroviral therapy	Antiretroviral therapy was administered as available and as per investigator's recommendation.

Timeline

• Start date: 2023-10-25
• Primary completion: 2024-06-24
• Completion: 2024-06-24
• First posted: 2023-09-15
• Last updated: 2025-09-30
• Results posted: 2025-09-30

Locations

20 sites across 9 countries: United States, Argentina, Canada, France, Germany, Italy, Mexico, Spain, United Kingdom

Regulatory

• FDA-regulated drug study