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New HIV pill VH4770359 enters first human safety tests

NCT ID NCT07525544

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jul 14, 2026 · Updated 3 times

Summary

This early-stage study tests a new experimental HIV drug called VH4770359 in 214 healthy adults aged 18-55. The goal is to check its safety, side effects, and how the body processes it. Participants will take either the drug or a placebo, and some will also receive midazolam to see if the new drug interacts with other medicines. Results will help design future studies in people living with HIV.

What this could mean

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

Active substance
VH4770359 (an experimental oral antiretroviral drug)
What this could lead to
If successful, this could lead to a new oral medication for controlling HIV, offering another option for people living with the virus.
What could go wrong
This is a very early, first-in-human study in healthy people, not those with HIV. It only tests safety and dosing; it may not work in patients or may have side effects.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 214 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

May 2027

An estimate. End dates often move.

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 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: 1. 18 to 55 years old 2. BMI 18.5-37.0 kg/m2 3. Male participants must adhere to contraception requirements or abstinence, and female participants must not be pregnant/breastfeeding and be of non-childbearing potential. Exclusion Criteria: 1. Participants with significant medical history that could alter drug pharmacokinetics, pose a risk, or interfere with conduct. 2. Has exclusionary psychiatric, hepatic, cardiovascular, gastrointestinal, respiratory, endocrine, neurological, hematological, or renal condition, or exclusionary malignancy. 3. A positive test(s) for Hepatitis B surface antigen (HBsAg) and/or anti-HBc, hepatitis C antibodies, or human immunodeficiency virus (HIV). 4. A history of or ongoing high-risk behaviors for HIV acquisition. 5. Use of prohibited medications. 6. Exclusionary allergies or sensitivities. 7. Regular use of alcohol, drugs of abuse, tobacco, or nicotine products. 8. Exclusionary prior or concurrent clinical study participation.

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Conditions

The condition(s) this trial relates to.

AIDS HIV infectious disease

As listed by the trial registrant

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

HIV infections

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • GSK Investigational Site

    RECRUITING

    Baltimore, Maryland, 21225, United States

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