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VH4524184

Phase 2

HIV Infections | Small molecule | Infectious Disease |GSK plc|Last Updated: Aug 10, 2026

Target and mechanism

ModalitySmall molecule

Also known as Oral VH4524184

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials7
Total Enrollment825

FDA Designations

No designations recorded

Clinical trial landscape

VH4524184 · 7 trials · 1 indication

Phase 2 2Phase 1 5
NCT07202546A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study)HIV Infections
RECRUITING186 Analytics
NCT06214052VH4524184 Proof-of-Concept in Treatment-Naïve Adults Living With HIV-1HIV Infections
COMPLETED22 Analytics
PHASE2RECRUITING
A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study)
HIV Infections
NCT07202546186
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PHASE2COMPLETED
VH4524184 Proof-of-Concept in Treatment-Naïve Adults Living With HIV-1
HIV Infections
NCT0621405222
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Study Endpoints

Primary Endpoints

Percentage of Participants Achieving Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) Suppression (<50 copies/millilitre) as per FDA Snapshot Methodology
At Month 12
Monotherapy: Maximum Change From Baseline in Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA)
At Day 10

Plasma samples were collected for the quantitative analysis of plasma HIV-1 RNA. The maximum change from baseline was calculated by determining the largest change from baseline value across all assessment timepoints during the monotherapy period. This is identified by subtracting the lowest post-dose visit value up to Day 10 (inclusive) from the baseline value. The baseline was defined as the most recent pre-dose assessment with a valid, non-missing value, including measurements from any unscheduled visits.

Absolute bioavailability (F oral) of VH4524184 (Period 1)
Day 1 up to Day 14
Amount of total radioactivity (TRA) excreted in urine (Ae urine) (Period 1)
Day 1 up to Day 14

Urine is collected until amount of radioactivity recovered in excreta (urine and feces) is at least 90% of administered radioactivity and \<1% has been recovered from excreta from 2 consecutive days (ie, the total for urine and feces is \<1% on 2 consecutive days).

Amount of TRA excreted in urine (Ae urine) (Period 2)
Day 15 up to Day 43

Urine is collected until amount of radioactivity recovered in excreta (urine and feces) is at least 90% of administered radioactivity and \<1% has been recovered from excreta from 2 consecutive days (ie, the total for urine and feces is \<1% on 2 consecutive days).

Amount of TRA excreted in feces (Ae feces) (Period 1)
Day 1 up to Day 14

Feces are collected until amount of radioactivity recovered in excreta (urine and feces) is at least 90% of administered radioactivity and \<1% has been recovered from excreta from 2 consecutive days (ie, the total for urine and feces is \<1% on 2 consecutive days).

Amount of TRA excreted in feces (Ae feces) (Period 2)
Day 15 up to Day 43

Feces are collected until amount of radioactivity recovered in excreta (urine and feces) is at least 90% of administered radioactivity and \<1% has been recovered from excreta from 2 consecutive days (ie, the total for urine and feces is \<1% on 2 consecutive days).

Amount of TRA excreted in vomitus (Ae vomit) (Period 1)
At Day 1
Amount of TRA excreted in vomitus (Ae vomit) (Period 2)
At Day 15
Total amount of TRA excreted (Ae total) (Period 1)
From Day 1 up to Day 14

The Ae of TRA measured in urine, feces and vomitus (if applicable on Day 1 only). Urine and feces are collected until amount of radioactivity recovered in excreta (urine and feces) is at least 90% of administered radioactivity and \<1% has been recovered from excreta from 2 consecutive days (ie, the total for urine and feces is \<1% on 2 consecutive days).

Total amount of TRA excreted (Ae total) (Period 2)
Day 15 up to Day 43

The Ae of TRA measured in urine, feces and vomitus (if applicable on Day 15 only). Urine and feces are collected until amount of radioactivity recovered in excreta (urine and feces) is at least 90% of administered radioactivity and \<1% has been recovered from excreta from 2 consecutive days (ie, the total for urine and feces is \<1% on 2 consecutive days).

Fraction of TRA excreted in urine (fe urine) (Period 1)
Day 1 up to Day 14

Urine is collected until the amount of radioactivity recovered in excreta (urine and feces) is at least 90% of administered radioactivity and \<1% has been recovered from excreta from 2 consecutive days (ie, the total for urine and feces is \<1% on 2 consecutive days).

Fraction of TRA excreted in urine (fe urine) (Period 2)
Day 15 up to Day 43

Urine is collected until amount of radioactivity recovered in excreta (urine and feces) is at least 90% of administered radioactivity and \<1% has been recovered from excreta from 2 consecutive days (ie, the total for urine and feces is \<1% on 2 consecutive days).

Fraction of TRA excreted in feces (fe feces) (Period 1)
Day 1 up to Day 14

Feces is collected until amount of radioactivity recovered in excreta (urine and feces) is at least 90% of administered radioactivity and \<1% has been recovered from excreta from 2 consecutive days (ie, the total for urine and feces is \<1% on 2 consecutive days).

Fraction of TRA excreted in feces (fe feces) (Period 2)
Day 15 up to Day 43

Feces is collected until amount of radioactivity recovered in excreta (urine and feces) is at least 90% of administered radioactivity and \<1% has been recovered from excreta from 2 consecutive days (ie, the total for urine and feces is \<1% on 2 consecutive days).

Fraction of TRA excreted in vomitus (fe vomit) (Period 1)
At Day 1
Fraction of TRA excreted in vomitus (fe vomit) (Period 2)
At Day 15
Total fraction of TRA excreted (fe total) (Period 1)
Day 1 up to Day 14

The fe of TRA measured in urine, feces and vomitus (if applicable on Day 1 only). Urine and feces are collected until amount of radioactivity recovered in excreta (urine and feces) is at least 90% of administered radioactivity and \<1% has been recovered from excreta from 2 consecutive days (ie, the total for urine and feces is \<1% on 2 consecutive days).

Total fraction of TRA excreted (fe total) (Period 2)
Day 15 up to Day 43

The fe of TRA measured in urine, feces and vomitus (if applicable on Day 15 only). Urine and feces are collected until amount of radioactivity recovered in excreta (urine and feces) is at least 90% of administered radioactivity and \<1% has been recovered from excreta from 2 consecutive days (ie, the total for urine and feces is \<1% on 2 consecutive days).

Maximum concentration (Cmax) of VH4524184 in plasma (Period 1)
Day 1 to Day 14
Maximum concentration (Cmax) of VH4524184 in plasma (Period 2)
Day 15 to Day 43
Maximum concentration (Cmax) of [14C]VH4524184 in plasma (Period 1)
Day 1 to Day 14
Maximum concentration (Cmax) of TRA in plasma (Period 1)
Day 1 to Day 14
Maximum concentration (Cmax) of TRA in plasma (Period 2)
Day 15 to Day 43
Cmax of TRA in whole blood (Period 1)
Day 1 to Day 14
Cmax of TRA in whole blood (Period 2)
Day 15 to Day 43
Time to maximum concentration (tmax) of VH4524184 in plasma (Period 1)
Day 1 to Day 14
Time to maximum concentration (tmax) of VH4524184 in plasma (Period 2)
Day 15 to Day 43
Time to maximum concentration (tmax) of [14C]VH4524184 in plasma (Period 1)
Day 1 to Day 14
Time to maximum concentration (tmax) of TRA in plasma (Period 1)
Day 1 to Day 14
Time to maximum concentration (tmax) of TRA in plasma (Period 2)
Day 15 to Day 43
Time to maximum concentration (tmax) of TRA in whole blood (Period 1)
Day 1 to Day 14
Time to maximum concentration (tmax) of TRA in whole blood (Period 2)
Day 15 to Day 43
Area under the concentration-time curve from time zero to the last measured timepoint (AUC 0-t) of VH4524184 in plasma (Period 1)
Day 1 to Day 14
Area under the concentration-time curve from time zero to the last measured timepoint (AUC 0-t) of VH4524184 in plasma (Period 2)
Day 15 to Day 43
Area under the concentration-time curve from time zero to the last measured timepoint (AUC 0-t) of [14C]VH4524184 in plasma (Period 1)
Day 1 to Day 14
Area under the concentration-time curve from time zero to the last measured timepoint (AUC 0-t) of TRA in plasma (Period 1)
Day 1 to Day 14
Area under the concentration-time curve from time zero to the last measured timepoint (AUC 0-t) of TRA in plasma (Period 2)
Day 15 to Day 43
Area under the concentration-time curve from time zero to the last measured timepoint (AUC 0-t) of TRA in whole blood (Period 1)
Day 1 to Day 14
Area under the concentration-time curve from time zero to the last measured timepoint (AUC 0-t) of TRA in whole blood (Period 2)
Day 15 to Day 43
Area under the concentration-time curve from time zero to infinity (AUC 0-inf) of VH4524184 in plasma (Period 1)
Day 1 to Day 14
Area under the concentration-time curve from time zero to infinity (AUC 0-inf) of VH4524184 in plasma (Period 2)
Day 15 up to Day 43
Area under the concentration-time curve from time zero to infinity (AUC 0-inf) of [14C]VH4524184 in plasma (Period 1)
Day 1 to Day 14
Area under the concentration-time curve from time zero to infinity (AUC 0-inf) of TRA in plasma (Period 1)
Day 1 to Day 14
Area under the concentration-time curve from time zero to infinity (AUC 0-inf) of TRA in plasma (Period 2)
Day 15 to 43
Area under the concentration-time curve from time zero to infinity (AUC 0-inf) of TRA in whole blood (Period 1)
Day 1 to Day 14
Area under the concentration-time curve from time zero to infinity (AUC 0-inf) of TRA in whole blood (Period 2)
Day 15 to Day 43
Amount of VH4524184 excreted in urine (Ae urine) (Period 2)
Day 15 to Day 43
Fraction of VH4524184 excreted in urine (fe urine) (Period 2)
Day 15 to Day 43
Renal clearance of VH4524184 (CL R) (Period 2)
Day 15 to Day 43
Part 1: Maximum plasma concentration (Cmax) for VH4524184
Up to Day 18
Part 1: Area under the concentration-time curve from 0 to tau (AUC0-t) for VH4524184
Up to day 18
Part 1: Area under the concentration-time curve from 0 to infinity (AUC0-inf) for VH4524184
Up to day 18
Part 2: Cmax for VH4524184
At Day 1, Day 14, Day 19 and Day 22
Part 2: AUC0-t of VH4524184
At Day 1, Day 14, Day 19 and Day 22
Part 2: AUC0-inf of VH4524184
At Day 1, Day 14, Day 19 and Day 22
Part 2: Cmax for metformin
At Day 1 and Day 15
Part 2: AUC0-t for metformin
At Day 1 and Day 15
Part 2: Cmax for Digoxin
At Day 1 and Day 15
Part 2: AUC0-t for Digoxin
At Day 1 and Day 15
Percentage of participants reporting adverse events (AEs) and related AEs
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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 (AUC) from time zero (pre-dose) to the end of the dosing interval at steady state (AUC0-Tau, ss) of EE and NEA without coadministration with VH4524184
On Day 10

Blood samples will be collected at indicated timepoint for plasma EE and NEA PK analysis.

AUC0-Tau, ss of EE and NEA with coadministration with VH4524184
On Day 20

Blood samples will be collected at indicated timepoint for plasma EE and NEA PK analysis.

Maximum plasma concentration (Cmax) for EE and NEA without coadministration with VH4524184
On Day 10

Blood samples will be collected at indicated timepoint for plasma EE and NEA PK analysis.

Cmax for EE and NEA with coadministration with VH4524184
On Day 20

Blood samples will be collected at indicated timepoint for plasma EE and NEA PK analysis.

Part 1: Number of participants with serious adverse events (SAE) and non-serious adverse events (non-SAE)
Up to 4 weeks
Part 2: Number of participants with SAE and non-SAE
Up to 6.5 weeks
Part 3: Number of participants with SAE and non-SAE
Up to 6.5 weeks
Part 1: Number of participants with adverse events based on severity
Up to 4 weeks
Part 2: Number of participants with adverse events by severity
Up to 6.5 weeks
Part 3: Number of participants with adverse events based on severity
Up to 6.5 weeks
Part 1: Percentage of participants who discontinue treatment due to adverse events (AE)
Up to 4 weeks
Part 2: Percentage of participants who discontinue treatment due to AE
Up to 6.5 weeks
Part 3: Percentage of participants who discontinue treatment due to AE
Up to 6.5 weeks
Part 1: Change from Baseline in Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) and Alkaline phosphatase (ALP) (International units per liter)
Baseline (Day 1) and up to 4 weeks
Part 2: Change from Baseline in AST, ALT and ALP (International units per liter)
Baseline (Day 1) and up to 6.5 weeks
Part 3: Change from Baseline in AST, ALT and ALP (International units per liter)
Baseline (Day 1) and up to 6.5 weeks
Part 1: Change from Baseline in Total bilirubin and Direct bilirubin (Micromoles per liter)
Baseline (Day 1) and up to 4 weeks
Part 2: Change from Baseline in Total bilirubin and Direct bilirubin (Micromoles per liter)
Baseline (Day 1) and up to 6.5 weeks
Part 3: Change from Baseline in Total bilirubin and Direct bilirubin (Micromoles per liter)
Baseline (Day 1) and up to 6.5 weeks
Part 1: Change from Baseline in Prothrombin time and Partial Thromboplastin Time (Seconds)
Baseline (Day 1) and up to 4 weeks
Part 2: Change from Baseline in Prothrombin time and Partial Thromboplastin Time (Seconds)
Baseline (Day 1) and up to 6.5 weeks
Part 3: Change from Baseline in Prothrombin time and Partial Thromboplastin Time (Seconds)
Baseline (Day 1) and up to 6.5 weeks
Part 1: Change from Baseline in International normalized ratio (INR) (Ratio)
Baseline (Day 1) and up to 4 weeks
Part 2: Change from Baseline in INR (Ratio)
Baseline (Day 1) and up to 6.5 weeks
Part 3: Change from Baseline in INR (Ratio)
Baseline (Day 1) and up to 6.5 weeks
Part 1: Number of participants with maximum toxicity grade increase from Baseline in liver panel laboratory parameters; AST, ALT, ALP, Total bilirubin, Direct bilirubin, Prothrombin time, Partial Thromboplastin Time and INR
Baseline (Day 1) and up to 4 weeks
Part 2: Number of participants with maximum toxicity grade increase from Baseline in liver panel laboratory parameters; AST, ALT, ALP, Total bilirubin, Direct bilirubin, Prothrombin time, Partial Thromboplastin Time and INR
Baseline (Day 1) and up to 6.5 weeks
Part 3: Number of participant with maximum toxicity grade increase from Baseline in liver panel laboratory parameters; AST, ALT, ALP, Total bilirubin, Direct bilirubin, Prothrombin time, Partial Thromboplastin Time and INR
Baseline (Day 1) and up to 6.5 weeks
Part 1: Area under the plasma-concentration time curve from zero (pre-dose) extrapolated to infinite time (AUC[0-infinity]) following dosing of VH4524184
Up to 4 weeks
Part 2: Area under the plasma concentration-time curve from zero (pre-dose) to the end of the dosing interval at steady state (AUC[0-tau]) following dosing of VH4524184
Up to 6.5 weeks
Part 1: Maximum observed plasma drug concentration (Cmax) following dosing of VH4524184
Up to 4 weeks
Part 2: Cmax following dosing of VH4524184
Up to 6.5 weeks
Part 1: Time to maximum observed plasma drug concentration (tmax) following dosing of VH4524184
Up to 4 weeks
Part 2: Tmax following dosing of VH4524184
Up to 6.5 weeks
Part 1: Apparent terminal half-life (t1/2) following dosing of VH4524184
Up to 4 weeks
Part 2: T1/2 following dosing of VH4524184
Up to 6.5 weeks

Secondary Endpoints

Percentage of Participants Maintaining Plasma HIV-1 RNA Suppression (<50 copies/mL) Based on Observed Laboratory Results
Day 1 to Month 24
Percentage of Participants Achieving Plasma HIV-1 RNA Suppression (<50 copies/ml) as per FDA Snapshot Methodology
Day 1 to Month 24
Change From Baseline in Cluster of Differentiation 4 (CD4+) T-cell Counts
Day 1 to Month 24
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
VH4524184 Dose A+ FTC / TAFEXPERIMENTALParticipants receive a daily oral dose of VH4524184 Dose A (Low dose) in combination with a fixed dose containing FTC/TAF starting Day 1 until Month 12.
VH4524184 Dose B + FTC / TAFEXPERIMENTALParticipants receive a daily oral dose of VH4524184 Dose B (High dose) in combination with a fixed dose containing FTC / TAF beginning on Day 1 until the Month 12.
DTG + 3TCACTIVE_COMPARATORParticipants receive a daily oral dose of DTG and 3TC (fixed dose combination) from Day 1 through Month 24.
VH4524184 selected dose + FTC / TAFEXPERIMENTALParticipants receive a selected dose of VH4524184, combined with FTC/TAF, orally once daily from to Month 12 to Month 24.
VH4524184 Dose 1EXPERIMENTALParticipants received VH4524184, administered as Dose 1 (low dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label standard-of-care (SOC) antiretroviral therapy (ART), which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
VH4524184 Dose 2EXPERIMENTALParticipants received VH4524184, administered as Dose 2 (medium dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
VH4524184 Dose 3EXPERIMENTALParticipants received VH4524184, administered as Dose 3 (high dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
PlaceboPLACEBO_COMPARATORParticipants received matching Placebo to the study intervention on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
VH4524184 GroupEXPERIMENTALParticipants will receive a dose of VH4524184 under fasting conditions, followed by a microdose of radiolabelled \[14C\]VH4524184 administered 2.5 hours after first dose administration at time zero on Day 1 (Period1). After a 14 days wash-out period participants will receive a radiolabelled dose of \[14C\]VH4524184 on Day 15 under fasting conditions.
Part 1A_VH4524184 (Sequence 1)EXPERIMENTALParticipants will receive VH4524184 tablet(s) of Dose level 1 followed by Dose level 2 in fasted condition.
Part 1A_VH4524184 (Sequence 2)EXPERIMENTALParticipants will receive VH4524184 tablet(s) of Dose level 2 followed by Dose level 1 in fasted condition.
Part 1A_VH4524184 (Sequence 3)EXPERIMENTALParticipants will receive VH4524184 tablet(s) of Dose level 3 followed by Dose level 2 in fasted condition.
Part 1A_VH4524184 (Sequence 4)EXPERIMENTALParticipants will receive VH4524184 tablet(s) of Dose level 2 followed by Dose level 3 in fasted condition.
Part 1B_VH4524184 (Sequence 5)EXPERIMENTALParticipants will receive VH4524184 tablet of Dose level 2 in fasted condition and then followed by intake of a high fat meal.
Part 1B_VH4524184 Sequence 6)EXPERIMENTALParticipants will receive VH4524184 tablet of Dose level 2 following a high fat meal and then in fasted condition.
Part 1B_VH4524184 (Sequence 7)EXPERIMENTALParticipants will receive VH4524184 tablet of Dose level 3 in fasted condition and then followed by intake of a high fat meal.
Part 1B_VH4524184 (Sequence 8)EXPERIMENTALParticipants will receive VH4524184 tablet of Dose level 3 following a high fat meal and then in a fasted condition.
Part 2_Cohort 1EXPERIMENTALParticipants will receive VH4524184 tablet and Itraconazole.
Part 2_Cohort 2AEXPERIMENTALParticipants will receive VH4524184 and Rifabutin.
Part 2_Cohort 2BEXPERIMENTALParticipants will receive VH4524184 tablet and Phenytoin.
Part 2_ Cohort 3EXPERIMENTALParticipants will receive Metformin, Digoxin and VH4524184 tablets.
Formulation A SC GroupEXPERIMENTALParticipants receive a Formulation A starting dose of VH4524184 LAI subcutaneously (SC).
Formulation B SC GroupEXPERIMENTALParticipants receive a Formulation B starting dose of VH4524184 LAI subcutaneously (SC).
Formulation A IM GroupEXPERIMENTALParticipants receive a Formulation A starting dose of VH4524184 LAI intramuscularly (IM).
Formulation B IM GroupEXPERIMENTALParticipants receive a Formulation B starting dose of VH4524184 LAI intramuscularly (IM).
Multiple doses GroupEXPERIMENTALVH4524184 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.
Loestrin + VH4524184EXPERIMENTALEligible participants entering a run-in period of 21 days (Days -28 through -8) will receive Loestrin (EE and NEA) to stabilize on the combined OCs containing EE and NEA to synchronize the menstrual cycles of multiple participants. Participants completing the run-in period will enter Treatment Period 1 and will be administered Loestrin once daily from Days 1 to 10. On Day 11, participants will enter Treatment Period 2 and will be administered Loestrin + VH4524184 once daily from Days 11 to 20.
Part 1: Cohort 1: Participants receiving VH4524184 DL1EXPERIMENTALEligible participants will receive VH4524184 Dose Level 1 (DL1) during Cohort 1 of Part 1 of the study.
Part 1: Cohort 1: Participants receiving PlaceboPLACEBO_COMPARATOREligible participants will receive Placebo matching VH4524184 DL1 during Cohort 1 of Part 1 of the study.
Part 1: Cohort 2: Participants receiving VH4524184 DL2EXPERIMENTALEligible participants will receive VH4524184 DL2 during Cohort 2 of Part 1 of the study.
Part 1: Cohort 2: Participants receiving PlaceboPLACEBO_COMPARATOREligible participants will receive Placebo matching VH4524184 DL2 during Cohort 2 of Part 1 of the study.
Part 1: Cohort 3: Participants receiving VH4524184 DL3EXPERIMENTALEligible participants will receive VH4524184 DL3 during Cohort 3 of Part 1 of the study.
Part 1: Cohort 3: Participants receiving PlaceboPLACEBO_COMPARATOREligible participants will receive Placebo matching VH4524184 DL3 during Cohort 3 of Part 1 of the study.
Part 1: Cohort 4: Participants receiving VH4524184 DL4EXPERIMENTALEligible participants will receive VH4524184 DL4 during Cohort 4 of Part 1 of the study.
Part 1: Cohort 4: Participants receiving PlaceboPLACEBO_COMPARATOREligible participants will receive Placebo matching VH4524184 DL4 during Cohort 4 of Part 1 of the study.
Part 1: Cohort 5: Participants receiving VH4524184 DL5EXPERIMENTALEligible participants will receive VH4524184 DL5 during Cohort 5 (optional) of Part 1 of the study.
Part 1: Cohort 5: Participants receiving PlaceboPLACEBO_COMPARATOREligible participants will receive Placebo matching VH4524184 DL5 during Cohort 5 (optional) of Part 1 of the study.
Part 1: Cohort 6: Participants receiving VH4524184 DL6EXPERIMENTALEligible participants will receive VH4524184 DL6 during Cohort 6 (optional) of Part 1 of the study.
Part 1: Cohort 6: Participants receiving PlaceboPLACEBO_COMPARATOREligible participants will receive Placebo matching VH4524184 DL6 during Cohort 6 (optional) of Part 1 of the study.
Part 2: Cohort 7: Participants receiving VH4524184 RL1EXPERIMENTALEligible participants will receive VH4524184 Repeat dose Level 1 (RL1) during Cohort 7 (Part 2) of the study.
Part 2: Cohort 7: Participants receiving PlaceboPLACEBO_COMPARATOREligible participants will receive Placebo matching VH4524184 RL1 during Cohort 7 (Part 2) of the study.
Part 2: Cohort 8: Participants receiving VH4524184 RL2EXPERIMENTALEligible participants will receive VH4524184 RL2 during Cohort 8 (Part 2) of the study. If Cohort 8 is the highest Part 2 dose cohort, participants may also receive midazolam probe before and following repeat dose administration of VH4524184
Part 2: Cohort 8: Participants receiving PlaceboPLACEBO_COMPARATOREligible participants will receive Placebo matching VH4524184 RL2 during Cohort 8 (Part 2) of the study. If Cohort 8 is the highest Part 2 dose cohort, participants may also receive midazolam probe before and following repeat dose administration of Placebo matching VH4524184.
Part 2: Cohort 9: Participants receiving VH4524184 RL3EXPERIMENTALEligible participants will receive VH4524184 RL3 during Cohort 9 (Part 2) (optional) of the study. If Cohort 9 is the highest Part 2 dose cohort, participants may also receive midazolam probe before and following repeat dose administration of VH4524184.
Part 2: Cohort 9: Participants receiving PlaceboPLACEBO_COMPARATOREligible participants will receive Placebo matching VH4524184 RL3 during Cohort 9 (Part 2) (optional) of the study. If Cohort 9 is the highest Part 2 dose cohort, participants may also receive midazolam probe before and following repeat dose administration of Placebo matching VH4524184.
Part 3: Cohort 10: VH4524184 Fasted/ VH4524184 FedEXPERIMENTALEligible participants will receive VH4524184 under fasted condition in Treatment Period 1 followed by VH4524184 under fed condition in Treatment Period 2 during Cohort 10 (Part 3) of the study. Treatment Periods will be separated by a washout period.

Interventions

NameTypeDescription
VH4524184DRUGOral tablet will be administered.
Emtricitabine (FTC) and tenofovir alafenamide (TAF) Fixed Dose Combination (FDC) tabletsDRUGOral table will be administered.
Dolutegravir / Lamivudine (DTG/3TC)DRUGOral tablets will be administered.
Matching PlaceboDRUGVH4524184 Matching Placebo was administered as tablets orally at Day 1.
Antiretroviral therapyDRUGAntiretroviral therapy was administered as available and as per investigator's recommendation.
[14C]VH4524184 microdoseDRUGA radiolabelled microdose of \[14C\]VH4524184 is administered 2.5 hours after VH4524184 dose administration on Day 1 (Period1).
[14C]VH4524184DRUGOne dose of radiolabelled \[14C\]VH4524184 is administered to participants at Day 15 (Period 2).
ItraconazoleDRUGItraconazole will be administered.
RifabutinDRUGRifabutin will be administered.
PhenytoinDRUGExtended phenytoin sodium will be administered.
MetforminDRUGMetformin will be administered.
DigoxinDRUGDigoxin will be administered.
Oral VH4524184DRUGVH4524184 to be taken orally.
VH4524184 Formulation A SCDRUGVH4524184 LAI Formulation A administered subcutaneously.
Placebo Formulation A SCDRUGPlacebo Formulation A administered subcutaneously.
rHuPH20DRUGrHuPH20 administered subcutaneously.
VH4524184 Formulation B SCDRUGVH4524184 LAI Formulation B administered subcutaneously.
Placebo Formulation B SCDRUGPlacebo Formulation B administered subcutaneously.
VH4524184 Formulation A IMDRUGVH4524184 LAI Formulation A administered intramuscularly.
Placebo Formulation A IMDRUGPlacebo Formulation A administered intramuscularly.
VH4524184 Formulation B IMDRUGVH4524184 LAI Formulation B administered intramuscularly.
Placebo Formulation B IMDRUGPlacebo Formulation B administered intramuscularly.
LoestrinDRUGLoestrin will be administered.
MidazolamDRUGMidazolam will be administered in the highest dose cohort in Part 2 (Cohorts 8 or 9).
PlaceboDRUGPlacebo will be administered.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites123

Inclusion Criteria: 1. Participant must be at least 18 years of age (or older, if required for adults by local regulations) at the time of signing the informed consent. 2. Screening CD4+ T-cell count \>200 cells/microlitre (µL). 3. Documented HIV-1 infection and Screening plasma HIV-1 RNA of ≥1000 ...

Countries:United StatesArgentinaAustraliaBelgiumCanadaFranceGermanyItalyJapanPolandPortugalSouth KoreaSpainTaiwanNetherlands
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Competitive Landscape -Bacterial Infections 61 trials (matched to "HIV Infections")

Top 20 of 28 competitors

CompanyTickerTrialsLead PhaseDrugs
Pfizer Inc.PFE5PHASE3VLA15
Sanofi SA Sponsored ADRSNY2PHASE3PCV21, 20vPCV
GSK plc Sponsored ADRGSK4PHASE2MenABCWY vaccine
Grifols, S.A. Sponsored ADR Class BGRFS1PHASE3Xembify
CorMedix Inc.CRMD2PHASE3catheter lock, Heparin
Sinovac Biotech Ltd.SVA4PHASE3Sinovac PCV13, Prevnar
Novartis AG Sponsored ADRNVS1PHASE2Cryptosporidium parvum oocysts, EDI048
Innoviva, Inc.INVA3PHASE2Eravacycline/kg
BiomX Inc.PHGE1PHASE2BX004
Merck & Co., Inc.MRK2PHASE1V118C, PCV20
ICON PlcICLR1PHASE2AV7909 Full Dose, AV7909 Half Dose
AstraZeneca PLCAZN1PHASE1AZD7760
BioNTech SE Sponsored ADRBNTX1PHASE1BNT163
60 Degrees Pharmaceuticals, Inc.SXTP1PHASE2Tafenoquine
Tarsus Pharmaceuticals, Inc.TARS1PHASE2TP-05 Low Dose
Moderna, Inc.MRNA1PHASE2mRNA-1982
AN2 Therapeutics, Inc.ANTX1PHASE2Epetraborole
Emergent BioSolutions Inc.EBS4 - AIGIV
Abbott LaboratoriesABT1N/AUndisclosed
CareDx, Inc.CDNA1 - Undisclosed
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Recent Changes (Last 90 Days)

MEDIUMAug 11, 2026NCT06310551lastUpdatePostDate: changed
MEDIUMAug 11, 2026NCT06310551lastUpdatePostDate: changed
MEDIUMAug 11, 2026NCT06310551lastUpdatePostDate: changed
LOWJul 24, 2026NCT07202546Enrollment: 150 → 186
LOWJul 24, 2026NCT07202546Enrollment: 150 → 186
LOWJul 2, 2026NCT07636928Status: NOT_YET_RECRUITING → RECRUITING
LOWJul 2, 2026NCT07636928Status: NOT_YET_RECRUITING → RECRUITING
LOWJul 2, 2026NCT07636928Status: NOT_YET_RECRUITING → RECRUITING
LOWJun 30, 2026NCT06310551Enrollment: 268 → 372
LOWJun 30, 2026NCT06310551Enrollment: 268 → 372
LOWJun 30, 2026NCT06310551Enrollment: 268 → 372
LOWJun 9, 2026NCT07636928NEW_TRIAL: changed
LOWJun 9, 2026NCT07636928NEW_TRIAL: changed
LOWJun 9, 2026NCT07636928NEW_TRIAL: changed
LOWJun 9, 2026NCT07636928NEW_TRIAL: changed

Frequently asked questions about VH4524184

What is VH4524184 used for?

VH4524184 is an investigational small molecule being developed for the treatment of HIV infections. It is currently in Phase 2 clinical development, with studies evaluating its safety, tolerability, and pharmacokinetics in adults living with HIV-1, as well as in healthy volunteers.

Who makes VH4524184?

VH4524184 is being developed by GSK plc, a global biopharma company listed on the London Stock Exchange under the ticker GSK. The company is conducting multiple clinical trials to evaluate the drug's potential as a treatment for HIV infections.

What phase is VH4524184 in?

VH4524184 is currently in Phase 2 clinical development. A Phase 2 proof-of-concept study in treatment-naïve adults living with HIV-1 has been completed, and additional Phase 1 studies have also been completed to assess safety, drug interactions, and food effects.

What clinical trials is VH4524184 in?

VH4524184 has been studied in several clinical trials, including NCT05631704 (Phase 1, completed), NCT06214052 (Phase 2 proof-of-concept, completed), NCT06310616 (Phase 1 drug interaction study, completed), and NCT07066722 (Phase 1 absorption and interaction study, completed). These trials enrolled a total of 258 participants across the United States, Argentina, Canada, Italy, and Spain.

Is VH4524184 the same as Oral VH4524184?

Yes, VH4524184 is also known as Oral VH4524184, reflecting its oral route of administration. The drug is being developed as an oral small molecule for the treatment of HIV infections, and both names refer to the same investigational compound.

How does VH4524184 work?

The specific molecular target of VH4524184 has not been disclosed in the available information. As a small molecule being developed for HIV infections, it is intended to interfere with the viral life cycle, but the exact mechanism of action has not been publicly detailed.