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

NCT06039579 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2025-09-30

Study results available
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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

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.

Sponsors & Collaborators

  • ViiV Healthcare

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-25
Primary Completion
2024-06-24
Completion
2024-06-24
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Canada
  • France
  • Germany
  • Italy
  • Mexico
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06039579 on ClinicalTrials.gov