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First Study of Long-Acting VH4524184 for HIV Infection

This study is the first to test new long-acting forms of VH4524184, a potential treatment for HIV infections. Researchers want to find out if different doses of VH4524184, given as an injection under the skin (subcutaneously), are safe and well-tolerated. They also want to see how the drug moves through the body to ensure it can work as a long-lasting HIV treatment. Some participants will receive oral VH4524184, while others will receive different injectable formulations (VH4524184 Formulation A SC, VH4524184 Formulation B SC), a placebo (an inactive substance), or rHuPH20. The study is looking for healthy adults between 18 and 55 years old. The main goal is to track any side effects and how severe they are.

Study design
This interventional study plans to enroll 372 participants. It is testing different formulations of VH4524184, including oral and subcutaneous injections, as well as a placebo.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for adverse events from the first dose up to 52 weeks after the last dose.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06310551

First Time in Human Study of Long Acting VH4524184 Formulations

Recruiting
PHASE1Ages 18–55InterventionalTreatment
ViiV Healthcare
~372 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:Oral VH4524184VH4524184 Formulation A SCPlacebo Formulation A SCrHuPH20VH4524184 Formulation B SCPlacebo Formulation B SC

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of participants reporting adverse events (AEs) and related AEs
Measured over From first study dose administration (Day 1) up to Week 52 post last dose, and Week 80 post last dose for a sub-group of participants
+18 more outcomes measured

Conditions

HIV Infections

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Healthy Volunteers

NCT06310551

Where you'd take part

This study runs at 3 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • GSK Investigational Site

    Lenexa, Kansasstudy coordinator listed

    Recruiting

  • GSK Investigational Site

    San Antonio, Texasstudy coordinator listed

    Recruiting

  • GSK Investigational Site

    Salt Lake City, Utahstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

US GSK Clinical Trials Call Center
[email protected]
877-379-3718
Email the study team

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Eligibility criteria

Inclusion

A participant of childbearing potential (POCBP) (female sex assigned at birth) is eligible to participate as long as the participant is not pregnant, breastfeeding and utilizes a highly effective method of contraception.
A participant of non-childbearing potential (PONCBP) is eligible to participate if all other eligibility criteria are met.

What this trial measures

  • Percentage of participants reporting adverse events (AEs) and related AEsFrom first study dose administration (Day 1) up to Week 52 post last dose, and Week 80 post last dose for a sub-group of participants

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Related AE = AE assessed by the investigator as related to the study drug.

  • Percentage of participants with AEs by severityFrom first dose administration (Day 1) up to Week 52 post last dose, and Week 80 post last dose for a sub-group of participants

    Severity of AEs will be assessed using Division of AIDS Table for Grading the Severity of Adult Adverse Events (DAIDS). DAIDS grading scale is used to grade the toxicity associated with injection site reactions (ISR) including injection site pain (or tenderness), erythema (or redness), induration (or swelling), and pruritus. The toxicity level is graded from Grade 1 (lowest toxicity) to 4 (highest toxicity). Higher grade indicates higher toxicity.

  • Percentage of participants discontinuing the treatment due to AEsFrom first dose administration (Day 1) up to Week 52 post last dose, and Week 80 post last dose for a sub-group of participants
  • Change from baseline in alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase parametersFrom first dose administration (Day 1) up to Week 52 post last dose, and Week 80 post last dose for a sub-group of participants

    The liver panel laboratory parameters are assessed after the administration of long-acting injectable (LAI) VH4524184.

  • Change from baseline in total bilirubin parametersFrom first dose administration (Day 1) up to Week 52 post last dose, and Week 80 post last dose for a sub-group of participants

    The liver panel laboratory parameters are assessed after the administration of LAI VH4524184.

  • Change from baseline in international normalized ratio (INR) parametersFrom first dose administration (Day 1) up to Week 52 post last dose, and Week 80 post last dose for a sub-group of participants

    The liver panel laboratory parameters are assessed after the administration of LAI VH4524184.

  • Maximum toxicity grade increase from baseline in ALT, AST and alkaline phosphataseFrom first dose administration (Day 1) up to Week 52 post last dose, and Week 80 post last dose for a sub-group of participants
  • Maximum toxicity grade increase from baseline in total bilirubinFrom first dose administration (Day 1) up to Week 52 post last dose, and Week 80 post last dose for a sub-group of participants
  • Maximum toxicity grade increase from baseline in INRFrom first dose administration (Day 1) up to Week 52 post last dose, and Week 80 post last dose for a sub-group of participants
  • Percentage of participants reporting injection site reaction (ISR) AEsFrom first dose administration (Day 1) up to Week 52 post last dose, and Week 80 post last dose for a sub-group of participants

    Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, and Grade 4 = potentially life threatening.

  • Duration of injection site reaction AEsFrom first dose administration (Day 1) up to Week 52 post last dose, and Week 80 post last dose for a sub-group of participants
  • Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinity time (AUC[0-inf]) of LAI VH4524184 following single dose administrationFrom first dose administration (Day 1) up to Week 52 post last dose, and Week 80 post last dose for a sub-group of participants
  • Area under the plasma drug concentration-time curve from zero (pre-dose) to the end of the dosing interval at steady state (AUC[0-t]) of LAI VH4524184 following multiple dose administrationFrom first dose administration (Day 1) up to Week 52 post last dose, and Week 80 post last dose for a sub-group of participants
  • Maximum observed plasma drug concentration (Cmax) of LAI VH4524184 following single dose administrationFrom first dose administration (Day 1) up to Week 52 post last dose, and Week 80 post last dose for a sub-group of participants
  • Cmax of LAI VH4524184 following multiple dose administrationFrom first dose administration (Day 1) up to Week 52 post last dose, and Week 80 post last dose for a sub-group of participants
  • Time to maximum observed plasma drug concentration (Tmax) of LAI VH4524184 following single dose administrationFrom first dose administration (Day 1) up to Week 52 post last dose, and Week 80 post last dose for a sub-group of participants
  • Tmax of LAI VH4524184 following multiple dose administrationFrom first dose administration (Day 1) up to Week 52 post last dose, and Week 80 post last dose for a sub-group of participants
  • Apparent terminal half-life (t1/2) of LAI VH4524184 following single dose administrationFrom first dose administration (Day 1) up to Week 52 post last dose, and Week 80 post last dose for a sub-group of participants
  • t1/2 of LAI VH4524184 following multiple dose administrationFrom first dose administration (Day 1) up to Week 52 post last dose, and Week 80 post last dose for a sub-group of participants