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NCT06039579 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by ViiV Healthcare.

Completed
Registry status
Phase 2
Development phase
44
Enrollment target

NCT06039579: Completed Phase 2 study, sponsored by ViiV Healthcare.

NCT06039579 is a Phase 2 study that has completed, run by ViiV Healthcare. The registered enrollment target is 44 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06039579, a Phase 2 study, has completed, sponsored by ViiV Healthcare.

COMPLETED
Registry status
Phase 2
Development phase
44 participants
Enrollment target

Study 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.

Primary Outcome

Plasma samples were collected for quantitative analysis of plasma HIV-1 RNA. Maximum change from baseline was calculated by subtracting the baseline value from the post-dose visit value when the plasma HIV-1 RNA reached its minimum level up to Day 11 (inclusive). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. The results were expressed as log10 copies per milliliter (log10 c/mL).

Interventions

  • DRUG VH4004280
  • DRUG VH4011499
  • DRUG Antiretroviral therapy
  • DRUG VH4004280 Matching Placebo
  • DRUG VH4011499 Matching Placebo

Trial Details

FieldValue
Enrollment Target 44 participants
Start Date 2023-10-25
Est. Completion 2024-06-24
Phase Phase 2
ViiV Healthcare

182 total trials

What the finished NCT06039579 record still lists

NCT06039579 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% lower).

The record links to 0 conditions, and to 5 interventions - of which VH4004280 is the first listed.

NCT06039579 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT06039579 about?

NCT06039579 is a clinical study titled "Proof of Concept Treatment Study of Orally Administered VH4004280 or VH4011499 in HIV-1 Infected Adults". 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.

What is the current status of trial NCT06039579?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 44 participants. The study started on 2023-10-25. Estimated completion is 2024-06-24.

What interventions are being tested in trial NCT06039579?

The interventions under investigation include: VH4004280 (DRUG), VH4011499 (DRUG), Antiretroviral therapy (DRUG), VH4004280 Matching Placebo (DRUG), VH4011499 Matching Placebo (DRUG).

Who is sponsoring clinical trial NCT06039579?

This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT06039579's enrollment target sits among peer trials

44 1322nd of 2000 higher than 669 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06039579, the US trial registry maintained by the National Library of Medicine. NCT06039579 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.