HIV InfectionsPhase 1NCT06310551
First Time in Human Study of Long Acting VH4524184 Formulations
A Phase 1 study testing Oral VH4524184, VH4524184 Formulation A SC and rHuPH20 in people with HIV Infections, run by ViiV Healthcare at 5 sites in United States.
Trial summary
The purpose of this study is to identify 1 or more doses of parenterally administered VH4524184 that are safe, well tolerated and yield a PK drug exposure profile necessary to deliver a long-acting antiretroviral therapy for the treatment of HIV-1 infection. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Oral VH4524184, VH4524184 Formulation A SC and rHuPH20
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 348 participants
- Where
- 5 sitesUnited States
- Study dates
- 21 Mar 2024to 29 Jun 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age
- -Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
- Type of Participant and Characteristics
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
- Participants who are able to understand and comply with protocol requirements and timetables, instructions, and protocol-stated restrictions.
- Weight -Body weight ≥50.0 kg (110 lbs) for men and ≥45.0 kg (99 lbs) for women and body mass index within the range 18.5 to 32.0 kg/m^2 (inclusive) for all cohorts except B19. For Cohort B19, body mass index within the range >32.0 to 37.0 kg/m^2 (inclusive).
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- Sex and Contraceptive/Barrier Requirements
- Male or female
- Male Participants: No restrictions for male participants
- Participants of female sex assigned at birth:
- 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.
- Informed Consent
- Capable of providing signed informed consent.
Who cannot join
- Medical Conditions
- History or presence of clinical condition or disorder that could be capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study drug, interfering with the interpretation of data or would make the participant unsuitable for the study; unable to comply with dosing requirements; or unable to comply with study visits.
- Clinically significant abnormal blood pressure as determined by the investigator.
- 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.
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- Medical history of cardiac arrhythmias or cardiac disease or a family and personal history of long QT syndrome.
- Underlying skin disease or disorder that would interfere with the administration of study product and/or assessment of injection site reactions.
- Clinically significant history of drug hypersensitivity, delayed-type hypersensitivity or severe hypersensitivity reactions, as well as history of /sensitivity to any of the study interventions including hyaluronidases.
- Current or anticipated need for chronic anti-coagulation except for the use of low dose acetylsalicylic acid (≤325 mg) or hereditary coagulation and platelet disorders such as hemophilia or Von Willebrand Disease.
- History of seizure.
- Any known or suspected pre-existing psychiatric condition, including depression, anxiety and insomnia/sleep disturbances, at the discretion of the investigator.
- Any positive (abnormal) response confirmed by the investigator or clinician (or qualified designee) administered C-SSRS at screening.
- Insufficient muscle mass (gluteus medius or thigh) to support IM dose administration in the opinion of the investigator.
- Presence of tattoos, implants or skin piercings that may interfere with the administration of study product and/or assessment of ISRs, if they occur.
- History of or on-going high-risk behaviors that may put the participant at increased risk for HIV acquisition in the opinion of the investigator. This includes participants in HIV discordant relationships, or men who report current or prior unprotected anal sex with other men and those reporting prior or current injecting drug use.
- Prior/Concomitant Therapy
- 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) within 28 days prior to screening or 14 days before or after scheduled SC or IM dosing.
- Prior/Concurrent Clinical Study Experience
- 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 was administered within the last 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product before signing of consent (OR screening) any other clinical study.
- Participation in the study would result in loss of blood in excess of 500 mL over a 56-day period.
- Current enrollment or past participation in this clinical study, with the exception of participants who previously completed the Oral Lead In (OLI) but for operational or logistic reasons did not progress to CRU admission and receipt of injectable suspension for injection (SFI) or powder for suspension for injection (PFS) study medication or placebo, or prior participation in study 218803.
- Diagnostic Assessments
- eGFR <60 mL/min or serum creatinine >1.1 x ULN.
- Hemoglobin <12.5 g/dL for men and <11 g/dL for women
- ALT or AST > upper limit of normal (ULN).
- Total bilirubin >1.5xULN.
- Any significant arrhythmia or ECG finding.
- Exclusion criteria for Screening ECG - a single repeat is allowed for eligibility determination.
- Presence of HBsAg and/or anti-HBc at Screening or within 3 months prior to first dose of study intervention.
- Positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention.
- Positive pre-study drug/alcohol screen.
- Positive HIV antibody test.
- Other Exclusions
- Regular alcohol consumption within 6 months prior to the study defined as: An average weekly intake of >14 units for males or >7 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (~240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.
- 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, or other drug or other allergy that, in the opinion of the investigator or Sponsor Medical Monitor, contraindicates participation in the study.
- Fasting glucose >125 mg/dL (6.95 mmol/L) or receiving treatment for elevated blood glucose.
- Triglycerides >500 mg/dL (5.7 mmol/L) or receiving treatment for dyslipidemia.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
GSK Investigational Site
Austin, Texas, 78744
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Las Vegas, Nevada, 89113
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Lenexa, Kansas, 66219
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Salt Lake City, Utah, 84124
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
San Antonio, Texas, 78232
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
About this study
Official title: A Phase 1 Double-Blind (Sponsor-unblinded), Placebo-Controlled Randomized, Single Ascending Dose and Multiple Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Parenterally Administered VH4524184 in Healthy Adults
The purpose of this study is to identify 1 or more doses of parenterally administered VH4524184 that are safe, well tolerated and yield a PK drug exposure profile necessary to deliver a long-acting antiretroviral therapy for the treatment of HIV-1 infection.
- Conditions
- HIV Infections
- Being tested
- Oral VH4524184, VH4524184 Formulation A SC, Placebo Formulation A SC, rHuPH20, VH4524184 Formulation B SC
- Keywords
- Safety, Tolerability, Parenteral, First Time in Human, Pharmacokinetics, Ascending Dose, Multiple Dose, Healthy Adults
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral VH4524184Drug
VH4524184 to be taken orally.
VH4524184 Formulation A SCDrug
VH4524184 LAI Formulation A administered subcutaneously.
Placebo Formulation A SCDrug
Placebo Formulation A administered subcutaneously.
rHuPH20Drug
Also called Halozyme ENHANZE
rHuPH20 administered subcutaneously.
VH4524184 Formulation B SCDrug
VH4524184 LAI Formulation B administered subcutaneously.
Placebo Formulation B SCDrug
Placebo Formulation B administered subcutaneously.
VH4524184 Formulation A IMDrug
VH4524184 LAI Formulation A administered intramuscularly.
Placebo Formulation A IMDrug
Placebo Formulation A administered intramuscularly.
VH4524184 Formulation B IMDrug
VH4524184 LAI Formulation B administered intramuscularly.
Placebo Formulation B IMDrug
Placebo Formulation B administered intramuscularly.
| Study group | Role | What they receive |
|---|---|---|
| Formulation A SC Group | Experimental | Participants receive a Formulation A starting dose of VH4524184 LAI subcutaneously (SC). Receives: Drug: Oral VH4524184; Drug: VH4524184 Formulation A SC; Drug: Placebo Formulation A SC; Drug: rHuPH20 |
| Formulation B SC Group | Experimental | Participants receive a Formulation B starting dose of VH4524184 LAI subcutaneously (SC). Receives: Drug: Oral VH4524184; Drug: rHuPH20; Drug: VH4524184 Formulation B SC; Drug: Placebo Formulation B SC |
| Formulation A IM Group | Experimental | Participants receive a Formulation A starting dose of VH4524184 LAI intramuscularly (IM). Receives: Drug: Oral VH4524184; Drug: VH4524184 Formulation A IM; Drug: Placebo Formulation A IM |
| Formulation B IM Group | Experimental | Participants receive a Formulation B starting dose of VH4524184 LAI intramuscularly (IM). Receives: Drug: Oral VH4524184; Drug: VH4524184 Formulation B IM; Drug: Placebo Formulation B IM |
| Multiple doses Group | Experimental | VH4524184 LAI formulations administered SC or IM as single doses that achieve adequate PK exposure targets, may be evaluated for safety and tolerability as multiple doses. Receives: Drug: Oral VH4524184; Drug: VH4524184 Formulation A SC; Drug: Placebo Formulation A SC; Drug: rHuPH20; Drug: VH4524184 Formulation B SC; Drug: Placebo Formulation B SC; Drug: VH4524184 Formulation A IM; Drug: Placebo Formulation A IM; Drug: VH4524184 Formulation B IM; Drug: Placebo Formulation B IM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants reporting adverse events (AEs) and related AEs
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.
Measured: 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
Percentage of participants with AEs by severity
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.
Measured: From 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 discontinuing the treatment due to AEs
Measured: From 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 parameters
The liver panel laboratory parameters are assessed after the administration of long-acting injectable (LAI) VH4524184.
Measured: From 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 total bilirubin parameters
The liver panel laboratory parameters are assessed after the administration of LAI VH4524184.
Measured: From 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 international normalized ratio (INR) parameters
The liver panel laboratory parameters are assessed after the administration of LAI VH4524184.
Measured: From 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 ALT, AST and alkaline phosphatase
Measured: From 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 bilirubin
Measured: From 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 INR
Measured: From 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) AEs
Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, and Grade 4 = potentially life threatening.
Measured: From first dose administration (Day 1) up to Week 52 post last dose, and Week 80 post last dose for a sub-group of participants
Duration of injection site reaction AEs
Measured: From 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 administration
Measured: From 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 administration
Measured: From 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 administration
Measured: From 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 administration
Measured: From 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 administration
Measured: From 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 administration
Measured: From 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 administration
Measured: From 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 administration
Measured: From first dose administration (Day 1) up to Week 52 post last dose, and Week 80 post last dose for a sub-group of participants
Secondary outcomes (1)
Percentage of participants with treatment emergent Grade 3 or Grade 4 laboratory abnormalities
Grade 3 is defined as causing an inability to perform usual social \& functional activities with intervention or hospitalization indicated. Grade 4 is defined as an abnormality that is potentially life-threatening, causing an inability to perform basic self-care functions with intervention indicated to prevent permanent impairment, persistent disability, or death.
Measured: From first dose administration (Day 1) up to Week 52 post last dose, and Week 80 post last dose for a sub-group of participants
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start21 Mar 2024
- Primary completion28 May 2029 (estimated)
- Study completion29 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by ViiV HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 348 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ViiV Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06310551
- Sponsor's protocol ID
- 218804
- Other IDs
- NCT06310551
- Status last verified
- Nov 2026
- First submitted
- 5 Mar 2024
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.viiv-studyregister.com/documents/About\_ViiV\_Patient\_Level\_Data\_Sharing\_Final\_28May2026.pdf
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Double-Blind (Sponsor-unblinded), Placebo-Controlled Randomized, Single Ascending Dose and Multiple Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Parenterally Administered VH4524184 in Healthy Adults
- ClinicalTrials.gov ID
- NCT06310551
- Acronym / sponsor ID
- 218804
- Conditions
- HIV Infections
- Keywords
- Safety, Tolerability, Parenteral, First Time in Human, Pharmacokinetics, Ascending Dose, Multiple Dose, Healthy Adults
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 348 participants (estimated)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Study start
- 21 Mar 2024 (actual)
- Primary completion
- 28 May 2029 (estimated)
- Study completion
- 29 Jun 2029 (estimated)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to identify 1 or more doses of parenterally administered VH4524184 that are safe, well tolerated and yield a PK drug exposure profile necessary to deliver a long-acting antiretroviral therapy for the treatment of HIV-1 infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Formulation A SC Group | Experimental | Drug: Oral VH4524184, Drug: VH4524184 Formulation A SC, Drug: Placebo Formulation A SC, Drug: rHuPH20Participants receive a Formulation A starting dose of VH4524184 LAI subcutaneously (SC). |
| Formulation B SC Group | Experimental | Drug: Oral VH4524184, Drug: rHuPH20, Drug: VH4524184 Formulation B SC, Drug: Placebo Formulation B SCParticipants receive a Formulation B starting dose of VH4524184 LAI subcutaneously (SC). |
| Formulation A IM Group | Experimental | Drug: Oral VH4524184, Drug: VH4524184 Formulation A IM, Drug: Placebo Formulation A IMParticipants receive a Formulation A starting dose of VH4524184 LAI intramuscularly (IM). |
| Formulation B IM Group | Experimental | Drug: Oral VH4524184, Drug: VH4524184 Formulation B IM, Drug: Placebo Formulation B IMParticipants receive a Formulation B starting dose of VH4524184 LAI intramuscularly (IM). |
| Multiple doses Group | Experimental | Drug: Oral VH4524184, Drug: VH4524184 Formulation A SC, Drug: Placebo Formulation A SC, Drug: rHuPH20, Drug: VH4524184 Formulation B SC, Drug: Placebo Formulation B SC, Drug: VH4524184 Formulation A IM, Drug: Placebo Formulation A IM, Drug: VH4524184 Formulation B IM, Drug: Placebo Formulation B IMVH4524184 LAI formulations administered SC or IM as single doses that achieve adequate PK exposure targets, may be evaluated for safety and tolerability as multiple doses. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Age
- -Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
- Type of Participant and Characteristics
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
- Participants who are able to understand and comply with protocol requirements and timetables, instructions, and protocol-stated restrictions.
Key exclusion criteria (42 listed)
- Medical Conditions
- History or presence of clinical condition or disorder that could be capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study drug, interfering with the interpretation of data or would make the participant unsuitable for the study; unable to comply with dosing requirements; or unable to comply with study visits.
- Clinically significant abnormal blood pressure as determined by the investigator.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral VH4524184VH4524184 to be taken orally. | Drug | Formulation A IM Group, Formulation A SC Group, Formulation B IM Group, Formulation B SC Group, Multiple doses Group |
| VH4524184 Formulation A SCVH4524184 LAI Formulation A administered subcutaneously. | Drug | Formulation A SC Group, Multiple doses Group |
| Placebo Formulation A SCPlacebo Formulation A administered subcutaneously. | Drug | Formulation A SC Group, Multiple doses Group |
| rHuPH20Also: Halozyme ENHANZErHuPH20 administered subcutaneously. | Drug | Formulation A SC Group, Formulation B SC Group, Multiple doses Group |
| VH4524184 Formulation B SCVH4524184 LAI Formulation B administered subcutaneously. | Drug | Formulation B SC Group, Multiple doses Group |
| Placebo Formulation B SCPlacebo Formulation B administered subcutaneously. | Drug | Formulation B SC Group, Multiple doses Group |
| VH4524184 Formulation A IMVH4524184 LAI Formulation A administered intramuscularly. | Drug | Formulation A IM Group, Multiple doses Group |
| Placebo Formulation A IMPlacebo Formulation A administered intramuscularly. | Drug | Formulation A IM Group, Multiple doses Group |
| VH4524184 Formulation B IMVH4524184 LAI Formulation B administered intramuscularly. | Drug | Formulation B IM Group, Multiple doses Group |
| Placebo Formulation B IMPlacebo Formulation B administered intramuscularly. | Drug | Formulation B IM Group, Multiple doses Group |
Primary outcome
Percentage of participants reporting adverse events (AEs) and related AEs
Time frame: 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
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 severity
Time frame: From 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 AEs
Time frame: From 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 parameters
Time frame: From 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 parameters
Time frame: From 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) parameters
Time frame: From 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 phosphatase
Time frame: From 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 bilirubin
Time frame: From 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 INR
Time frame: From 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) AEs
Time frame: From 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 AEs
Time frame: From 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 administration
Time frame: From 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 administration
Time frame: From 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 administration
Time frame: From 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 administration
Time frame: From 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 administration
Time frame: From 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 administration
Time frame: From 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 administration
Time frame: From 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 administration
Time frame: From first dose administration (Day 1) up to Week 52 post last dose, and Week 80 post last dose for a sub-group of participants
1 secondary outcome
Percentage of participants with treatment emergent Grade 3 or Grade 4 laboratory abnormalities
Time frame: From first dose administration (Day 1) up to Week 52 post last dose, and Week 80 post last dose for a sub-group of participants
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: Yes. Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.viiv-studyregister.com/documents/About_ViiV_Patient_Level_Data_Sharing_Final_28May2026.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oral VH4524184, VH4524184 Formulation A SC and rHuPH20 in people with HIV Infections, run by ViiV Healthcare at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact US GSK Clinical Trials Call Center (877-379-3718, GSKClinicalSupportHD@gsk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants reporting adverse events (AEs) and related AEs (time frame: 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). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.