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New HIV capsid inhibitors show promise in early trial

NCT ID NCT06039579

Disease control Sponsor: ViiV Healthcare Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This completed Phase 2a trial tested two experimental oral drugs, VH4004280 and VH4011499, in 44 adults with HIV who had never taken antiretroviral therapy. The goal was to see how well these capsid inhibitors could lower the amount of virus in the blood over 10 days. The study also checked for side effects and how the body processes the drugs. Results are available but not yet published.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
VH4004280 and VH4011499 (oral capsid inhibitors)
What this could lead to
If successful, these oral capsid inhibitors could offer a new, convenient option for controlling HIV without daily pills.
What could go wrong
This is a small, early-phase trial (44 participants) testing short-term antiviral effect over 10 days. Long-term safety and efficacy are unknown, and the drugs may not work as well in larger studies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

44 people

The number who actually took part.

Started

Oct 2023

Finished

Jun 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participants who are overtly healthy (other than HIV-1 infection). * Screening cluster of differentiation-4 (CD4+) T-cell count greater than or equal to (≥)200 cells/microliter (µL). * Documented HIV-1 infection and Screening plasma HIV-1 RNA ≥3000 copies/milliliter (mL). * Treatment-naïve: Defined as no antiretroviral therapy received after the diagnosis of HIV-1 infection. Prior use of oral pre-exposure prophylaxis (PreP) is permitted. Prior use of parenteral PreP is exclusionary. * Has body mass index (BMI) within the range of 18.5-31.0 kilograms per meter square (kg/m\^2). * Participants male at birth must use male condoms and participants female at birth who are of childbearing potential must be using acceptable forms of birth control. * Participants capable of giving signed informed consent. * Participant must be willing and able to start locally accessible and commercially available combination antiretroviral therapy after the monotherapy period. Exclusion Criteria: * Women who are breastfeeding or plan to become pregnant or breast feed during the study. * Participants with acute HIV infection. * Any evidence of an active Centers for Disease Control and Prevention (CDC) Stage 3 disease. * Untreated syphilis infection. * Ongoing malignancy other than certain localised malignancies. * Treatment with immunomodulating agents or any agent with known anti-HIV activity. * Has exclusionary psychiatric, hepatic, cardiovascular gastrointestinal, renal condition. * Participant having any condition which, in the opinion of the investigator, may interfere with the absorption, distribution, metabolism or excretion of the study drugs or render the participant unable to take oral medication. * Participants having exclusionary electrocardiogram (ECG) findings. * Participants who have been exposed to any prohibited medication or vaccine. * Participant positive for hepatitis B or hepatitis C. * Participants with exclusionary safety laboratory (e.g Grade 3 or greater abnormality). * Participants who have positive results for illicit drug use, regular use of drugs of abuse and/or excessive alcohol use.

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Conditions

The condition(s) this trial relates to.

HIV infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV infections

Contacts and locations

Locations

  • GSK Investigational Site

    Bakersfield, California, 93301, United States

  • GSK Investigational Site

    DeLand, Florida, 32720, United States

  • GSK Investigational Site

    Newark, New Jersey, 07102, United States

  • GSK Investigational Site

    Buenos Aires, 1023, Argentina

  • GSK Investigational Site

    Buenos Aires, C1202ABB, Argentina

  • GSK Investigational Site

    Buenos Aires, C1425AGC, Argentina

  • GSK Investigational Site

    Ciudad Autonoma de Bueno, C1405CKC, Argentina

  • GSK Investigational Site

    Montreal, Quebec, H2L 4P9, Canada

  • GSK Investigational Site

    Marseille, 13003, France

  • GSK Investigational Site

    Nantes, 44093, France

  • GSK Investigational Site

    Paris, 75018, France

  • GSK Investigational Site

    Cologne, 50937, Germany

  • GSK Investigational Site

    Milan, 20157, Italy

  • GSK Investigational Site

    Guadalajara, 44160, Mexico

  • GSK Investigational Site

    Mexico City, 06760, Mexico

  • GSK Investigational Site

    Barcelona, 08907, Spain

  • GSK Investigational Site

    Barcelona, 08916, Spain

  • GSK Investigational Site

    Madrid, 28034, Spain

  • GSK Investigational Site

    Madrid, 28046, Spain

  • GSK Investigational Site

    London, SE5 8RX, United Kingdom

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