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New HIV drug candidate passes first safety check in healthy volunteers

NCT ID NCT05631704

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early-stage study tested a new experimental HIV drug called VH4524184 in 84 healthy adults to see if it is safe and how the body processes it. The study also looked at whether the drug affects a key liver enzyme. Because HIV requires lifelong treatment, this is not a cure but a step toward better disease control.

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

84 people

The number who actually took part.

Started

Dec 2022

Finished

Jul 2023

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 50 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: * Participant must be 18 to 50 years of age. * Participants who are overtly healthy. * Body weight \>=50.0 kilograms (kg) (110 pounds \[lbs\]) for men and \>=45.0 kg (99 lbs) for women and body mass index within the range 18.5 to 32.0 kilograms per meter square (kg/m\^2) (inclusive). * Male or female. Male Participants: No contraceptive restrictions for male participants. Female Participants: A female participant (female sex assigned at birth) is eligible to participate if she is not pregnant, or breastfeeding and is not physically able to have a baby. Exclusion Criteria: * History or presence of clinical condition that could significantly alter how medicines are absorbed, broken down or eliminated from the body; be risky to the participant, or make it difficult to interpret the data from the study. * Pre-existing clinically relevant gastro-intestinal disorders. * Abnormal blood pressure. * Certain blood or other cancers within the past 5 years. * Breast cancer within the past 10 years * Current or chronic history of liver disease or liver or bile tract abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). * QT interval corrected for heart rate according to Fridericia's formula (QTcF) \>450 milliseconds (msec). * Medical history of cardiac arrhythmias or cardiac disease or a family and personal history of long QT syndrome. * History of seizure * Any known or suspected pre-existing psychiatric condition, including depression, anxiety and insomnia/sleep disturbances. * Any positive (abnormal) response to the Columbia Suicide Severity Rating Scale (CSSRS). * Past or intended use of over-the-counter or prescription medication within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to dosing and for the duration of the study. * Receipt of any live vaccine(s) or vaccines against Coronavirus disease 2019 (Covid-19) within 28 days prior to screening or plans to receive such vaccines during the study. * Exposure to more than 4 new investigational products (including long-acting investigational products) within 12 months prior to the first dosing day. * Current enrollment or past participation in another investigational study in which an investigational intervention (e.g., drug, human blood product, monoclonal antibody, vaccine, invasive device) was administered within the last 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer) before signing of consent (OR screening) any other clinical study. * Participation in the study would result in loss of blood or blood products in excess of 500 milliliters (mL) over a 56-day period. * Current enrollment or past participation in this clinical study. * Estimated Glomerular Filtration Rate (eGFR) \<90 milliliters per minute (mL/min) (calculated using Chronic Kidney Disease Epidemiology Collaboration equation) or serum creatinine \>1.1 times Upper limit of normal (ULN). * Hemoglobin \<12.5 grams per deciliter (g/dL) for men and \<11 g/dL for women * ALT or AST \>1.5 times ULN * Total bilirubin \>1.5 times ULN (isolated bilirubin \>1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35 percent \[%\]). * Any significant arrhythmia or Electrocardiogram (ECG) finding * Exclusion criteria for Screening ECG (a single repeat is allowed for eligibility determination): Heart rate:\<45 or \>100 beats per minute (bpm) (Males), \<50 or \>100 bpm (Females); PR interval: \<120 or \>220 msec; QRS duration: \<70 or \>120 msec and QTcF interval: \>450 msec. * Presence of hepatitis B surface antigen (HBsAg) at screening. * Positive Hepatitis C antibody test result at screening * Positive pre-study drug/alcohol screen. * Positive human immunodeficiency virus (HIV) antibody test. * Regular alcohol consumption within 6 months prior to the study * Regular use of known drugs of abuse * Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening and at admission. * Sensitivity to the study drug, or components thereof, midazolam (For Part 2, midazolam probe cohort), excipients contained therein, benzodiazepines, or other drug or other allergy that, in the opinion of the investigator or Sponsor Medical Monitor, contraindicates participation in the study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • GSK Investigational Site

    Baltimore, Maryland, 21225, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.