New Long-Acting HIV prevention shot enters human safety trials
NCT ID NCT06724640
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tests a new long-acting injectable drug, VH4011499, in 168 healthy adults without HIV. The goal is to see if it is safe and how the body processes it, as a potential future option for HIV prevention. Participants receive one or more doses of the drug or a placebo and are monitored for side effects and drug levels in the blood.
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 168 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2024
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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 55 years of age inclusive, at the time of signing the informed consent. * Participants who are overtly healthy. * Participants may be male or female. Participants assigned female at birth are eligible to participate if they are not pregnant, not planning to become pregnant during the study, not breast/chest feeding or planning to breast/chest feed during the study and one of the following applies: * Is a Participant of Nonchildbearing potential (PONCBP) * Is a Participant of Childbearing potential (POCBP) and using a highly effective method of contraception through 78 weeks after the last dose of parenteral VH4011499 or through the end of the study. The investigator is responsible for review of medical history, menstrual history and recent sexual activity to decrease the risk for inclusion of a POCBP with an early pregnancy. * Capable of giving signed informed consent. Exclusion Criteria: * History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, neurological or psychiatric disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data. * Abnormal blood pressure. * Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years. * Breast cancer within the past 10 years. * Current or chronic history of liver disease, or known hepatic or biliary abnormalities. * History of clinically relevant hepatitis within last 6 months. * Patients with chronic hepatitis B infection. * History of sensitivity to any of the study interventions, a history of drug allergy or other allergy that contraindicates their participation. * The participant has an underlying skin disease or disorder that would interfere with assessment of injection sites. * Participants considered to have insufficient musculature to allow safe VH4011499 intramuscular administration will be excluded. * History of or on-going high-risk behaviors that may put the participant at increased risk for HIV acquisition. * Any preexisting physical or mental condition which may interfere with the participant's ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the participant. * Past or intended use over-the-counter or prescription medication (including herbal medications) within 7 days prior to dosing * Exposure to more than 4 new investigational products within 12 months prior to the first dosing day. * Current enrollment or recent past participation in another investigational study. * Positive HIV antibody/antigen test. * ALT more than or equal to (\>=)1.5x upper limit of normal (ULN), Total bilirubin \>=1.5x ULN (isolated total bilirubin more than (\>)1.5xULN), and/or estimated creatinine clearance (eGFR) of less than (\<)60 millilitre per minute (mL/min)/1.73 square meter (m\^2). * Regular use of tobacco or nicotine-containing products, regular alcohol consumption and/or use of known drugs of abuse. * QT interval corrected for heart rate according to Fridericia's formula (QTcF) \>450 msec. * Evidence of previous myocardial infarction, any conduction abnormality, any significant arrhythmia, non-sustained or sustained ventricular tachycardia, and/or sinus pauses (\>3 seconds). * The participant has a tattoo or other dermatological condition overlying the location of injection or a prior history of silicone implants or fillers which may interfere with interpretation of ISRs or administration of study product.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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GSK Investigational Site
RECRUITINGLas Vegas, Nevada, 89113, United States
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GSK Investigational Site
RECRUITINGAustin, Texas, 78744, United States
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Other studies related to the condition(s) this trial covers.
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