New HIV shot candidates enter first human safety tests
NCT ID NCT06012136
First seen Jun 26, 2026 · Last updated Aug 06, 2026 · Updated 2 times
Summary
This early-stage trial tests the safety and tolerability of two experimental injectable drugs (capsid inhibitors) in 85 healthy adults. Participants receive a single dose or multiple doses of the drug or a placebo. The goal is to see if these drugs are safe enough to study further as a potential long-acting HIV treatment.
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 (capsid inhibitors)
- What this could lead to
- If successful, this could lead to a new long-acting injectable option for controlling HIV, reducing the need for daily pills.
- What could go wrong
- This is a very early Phase 1 safety study in healthy people, not those with HIV. It is too soon to know if these drugs will work against HIV or be safe long-term.
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
-
85 people
The number who actually took part.
- Started
-
Aug 2023
- Finished
-
Jun 2026
- 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 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: * Participants who are overtly healthy. * Participants who are negative on a single test for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) (approved molecular polymerase chain reaction (PCR), point of care test), performed on the day of admission (Day -1). A negative result is required prior to the administration of study intervention on Day 1. * Male or female participants of non-childbearing potential. * 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 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 capsid inhibitor intramuscular (gluteus medius) administration. * History of or on-going high-risk behaviours that may put the participant at increased risk for HIV. * Past or intended use of over-the-counter or prescription medication including herbal medications. * Current enrollment or recent past participation in another investigational study. * Exposure to more than 4 investigational products within 12 months prior to dosing. * Alanine transaminase (ALT) ≥1.5x upper limit of normal (ULN), Total bilirubin ≥1.5x ULN (isolated total bilirubin \>1.5xULN), and/or estimated creatinine clearance (eGFR) of \<60 millilitre per minute (mL/min)/1.73 square meter (m\^2). * History of or current infection with hepatitis B or hepatitis C. * Positive SARS-CoV-2 polymerase chain reaction test, having signs and symptoms, or having contact with known coronavirus disease 2019 (COVID-19) positive person/s in the 14 days prior to inpatient admission. * Use of tobacco or nicotine-containing products, regular alcohol consumption and/or regular use of known drugs of abuse. * Positive HIV antibody/antigen test. * Abnormal electrocardiogram (ECG) parameters. * 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 (gluteal) which may interfere with interpretation of injection site reactions 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.
Contacts and locations
Locations
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GSK Investigational Site
Las Vegas, Nevada, 89113, United States
-
GSK Investigational Site
Austin, Texas, 78744, United States
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Other studies related to the condition(s) this trial covers.
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