Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as VH4011499 low dose Injection, VH4011499 low dose, GSK4011499
VH4011499 · 4 trials · 1 indication
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. Severity of AEs and ISR AEs including injection site pain (or tenderness), erythema (or redness), induration (or swelling), and pruritis, will be assessed using Division of Acquired Immunodeficiency Syndrome (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=potentially life threatening and Grade 5=Death.
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a study intervention whether or not considered related to the study intervention.
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a study intervention whether or not considered related to the study intervention.
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a study intervention whether or not considered related to the study intervention.
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a study intervention whether or not considered related to the study intervention. The Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric AE was used for all AE severity grading, where Grade 1=Mild symptoms causing no or minimal interference with usual social \& functional activities with intervention not indicated, 2=Moderate symptoms causing greater than minimal interference with usual social \& functional activities with intervention indicated, 3=Severe symptoms causing inability to perform usual social \& functional activities with intervention or hospitalization indicated, 4=Potentially life-threatening symptoms causing inability to perform basic self-care functions with intervention indicated to prevent permanent impairment, persistent disability or death, 5=Death.
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a study intervention whether or not considered related to the study intervention. The Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric AE was used for all AE severity grading, where Grade 1=Mild symptoms causing no or minimal interference with usual social \& functional activities with intervention not indicated, 2=Moderate symptoms causing greater than minimal interference with usual social \& functional activities with intervention indicated, 3=Severe symptoms causing inability to perform usual social \& functional activities with intervention or hospitalization indicated, 4=Potentially life-threatening symptoms causing inability to perform basic self-care functions with intervention indicated to prevent permanent impairment, persistent disability or death, 5=Death.
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a study intervention whether or not considered related to the study intervention. The Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric AE was used for all AE severity grading, where Grade 1=Mild symptoms causing no or minimal interference with usual social \& functional activities with intervention not indicated, 2=Moderate symptoms causing greater than minimal interference with usual social \& functional activities with intervention indicated, 3=Severe symptoms causing inability to perform usual social \& functional activities with intervention or hospitalization indicated, 4=Potentially life-threatening symptoms causing inability to perform basic self-care functions with intervention indicated to prevent permanent impairment, persistent disability or death, 5=Death.
Number of participants who discontinued treatment due to AEs are presented.
Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of bilirubin.
Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of ALT, ALP and AST.
Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of bilirubin.
Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of ALT, ALP and AST
Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of bilirubin.
Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of ALT, ALP and AST
Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of bilirubin. Change from baseline was calculated by subtracting the baseline value from the post-dose visit value.
Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of ALT, ALP and AST. Change from baseline was calculated by subtracting the baseline value from the post-dose visit value.
Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of bilirubin. Change from baseline was calculated by subtracting the baseline value from the post-dose visit value. Standard Deviation (SD)=0.0000 is defined as following: if all participants analyzed for a specific parameter at a specific time point have the same value, then SD is equal with 0.0000.
Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of ALT, ALP and AST. Change from baseline was calculated by subtracting the baseline value from the post-dose visit value. SD=0.00 is defined as following: if all participants analyzed for a specific parameter at a specific time point have the same value, then SD is equal with 0.00.
Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of bilirubin. Change from baseline was calculated by subtracting the baseline value from the post-dose visit value.
Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of ALT, ALP and AST. Change from baseline was calculated by subtracting the baseline value from the post-dose visit value.
Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of the liver panel parameters: ALT, ALP, AST, total bilirubin and direct bilirubin. The number of participants with any grade increase (from grade 1 \[mild\] to grade 4 \[potentially life-threatening\]) have been presented.
Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of the liver panel parameters: ALT, ALP, AST, total bilirubin and direct bilirubin. The number of participants with any grade increase (from grade 1 \[mild\] to grade 4 \[potentially life-threatening\]) have been presented.
Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of the liver panel parameters: ALT, ALP, AST, total bilirubin and direct bilirubin. The number of participants with any grade increase (from grade 1 \[mild\] to grade 4 \[potentially life-threatening\]) have been presented.
Blood samples were collected as assessed by protocol, at specific time points for pharmacokinetic (PK) analysis to determine AUC(0-inf). For AUC, a linear trapezoidal method was employed for all incremental trapezoids arising from increasing concentrations and the logarithmic trapezoidal method was used for those arising from decreasing concentrations. Geometric Coefficient of Variation was expressed in percentages.
Blood samples were collected as assessed by protocol, at specific time points for PK analysis to determine AUC(0-t). For AUC, a linear trapezoidal method was employed for all incremental trapezoids arising from increasing concentrations and the logarithmic trapezoidal method was used for those arising from decreasing concentrations.
Blood samples were collected as assessed by protocol, at specific time points for PK analysis to determine Cmax.
Blood samples were collected as assessed by protocol, at specific time points for PK analysis to determine Tmax.
Blood samples were collected as assessed by protocol, at specific time points for PK analysis to determine T1/2.
Blood samples were collected as assessed by protocol, at specific time points for PK analysis to determine Cmax.
Blood samples were collected as assessed by protocol, at specific time points for PK analysis to determine Tmax.
Blood samples were collected as assessed by protocol, at specific time points for PK analysis to determine T1/2.
| Arm | Type | Description |
|---|---|---|
| VH4011499 dose Group 1 + CAB | EXPERIMENTAL | Investigational long-acting injectable regimen consisting of VH4011499 (dose Group 1, which differs from all other arms) and cabotegravir (CAB). |
| VH4011499 dose Group 2 + CAB | EXPERIMENTAL | Investigational long-acting injectable regimen consisting of VH4011499 (dose Group 2, which differs from all other arms) and CAB. |
| VH4011499 dose Group 3 + CAB | EXPERIMENTAL | Investigational long-acting injectable regimen consisting of VH4011499 (dose Group 3, which differs from all other arms) and CAB. |
| VH4011499 dose Group 4 + CAB | EXPERIMENTAL | Investigational long-acting injectable regimen consisting of VH4011499 (dose Group 4, which differs from all other arms) and CAB. |
| DTG/3TC | ACTIVE_COMPARATOR | Active control arm receiving daily oral standard of care antiretroviral therapy (dolutegravir 50 mg / lamivudine 300 mg single-tablet regimen). |
| Single ascending dose (SAD) Group | EXPERIMENTAL | Participants in this group will be randomized to receive a single dose of either VH4011499 low dose or VH4011499 high dose or placebo. |
| Multiple ascending doses (MAD) Group | EXPERIMENTAL | Participants in this group will be randomized to receive two doses of either VH4011499 low dose or VH4011499 high dose or placebo. |
| Part 1 Dose A - Fasted condition | EXPERIMENTAL | VH4011499 Dose A tablet administered in fasted condition. |
| Part 1 Dose A- Fed condition (high fat meal) | EXPERIMENTAL | VH4011499 Dose A tablet administered in fed condition (high fat meal). |
| Part 2 Dose B - Optional - Fed condition (low fat meal) | EXPERIMENTAL | VH4011499 Dose B tablet administered in fed condition (low fat meal). |
| Part 3 Dose B - Fasted condition | EXPERIMENTAL | VH4011499 Dose B tablet administered in fasted condition. |
| Part 3 Dose B - Fed condition (high fat meal) | EXPERIMENTAL | VH4011499 Dose B tablet administered in fed condition (high fat meal). |
| Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB) | PLACEBO_COMPARATOR | Healthy participants were given a single dose of placebo on Day 1 and were followed up until Day 28. |
| Part 1 (SAD): VH4011499 25 mg PiB | PLACEBO_COMPARATOR | Healthy participants were given a single dose of 25 mg VH4011499 on Day 1 and were followed up until Day 28. |
| Part 1 (SAD): VH4011499 125 mg PiB | EXPERIMENTAL | Healthy participants were given a single dose of 125 mg VH4011499 on Day 1 and were followed up until Day 28. |
| Part 1 (SAD): VH4011499 200 mg PiB | EXPERIMENTAL | Healthy participants were given a single dose of 200 mg VH4011499 on Day 1 and were followed up until Day 28. |
| Part 1 (SAD): VH4011499 625 mg PiB | EXPERIMENTAL | Healthy participants were given a single dose of 625 mg VH4011499 on Day 1 and were followed up until Day 28. |
| Part 1 (SAD): VH4011499 1875 mg PiB | EXPERIMENTAL | Healthy participants were given a single dose of 1875 mg VH4011499 on Day 1 and were followed up until Day 28. |
| Part 2 Multiple Ascending Dose (MAD): Placebo PiB | PLACEBO_COMPARATOR | Healthy participants were given a dose of placebo once daily for a 14-day period and were followed up until Day 42. |
| Part 2 (MAD): VH4011499 200 mg PiB | EXPERIMENTAL | Healthy participants were given a dose of VH4011499 200 mg PiB once daily for a 14-day period and were followed up until Day 42. |
| Part 2 (MAD): VH4011499 300 mg + Midazolam (MDZ) PiB | EXPERIMENTAL | Healthy participants were given a dose of VH4011499 300 mg once daily and a single dose of Midazolam on Days 1, 2, and 15, and were followed up until Day 42. |
| Part 2 (MAD): VH4011499 400 mg PiB | EXPERIMENTAL | Healthy participants were given a dose of VH4011499 400 mg PiB once daily for a 14-day period and were followed up until Day 42. |
| Part 3 (Single dose): VH4011499 200 mg tablet | EXPERIMENTAL | Healthy participants were given a dose of VH4011499 200 mg tablet on Day 1 and were followed up until Day 28. |
| Name | Type | Description |
|---|---|---|
| VH4011499 | DRUG | Participants receive injectable VH4011499 at different dose groups. |
| CAB | DRUG | Participants receive injectable CAB. |
| DTG/3TC | DRUG | Participants receive DTG/3TC orally once daily. |
| VH4011499 low dose Injection | DRUG | VH4011499 low dose Injection will be administered subcutaneously and/or intramuscularly. |
| VH4011499 high dose Injection | DRUG | VH4011499 high dose Injection will be administered subcutaneously and/or intramuscularly. |
| Placebo | DRUG | Placebo Injection will be administered either subcutaneously or intramuscularly. |
| VH4011499 Dose A | DRUG | VH4011499 administered in fasted or fed conditions. |
| VH4011499 Dose B | DRUG | VH4011499 Dose B administered in fasted or fed conditions. |
| Midazolam | DRUG | Midazolam will be administered |
Inclusion Criteria: * Participant must be at least 18 years of age (or older, if required for adults by local regulations). * Screening CD4+ T-cell count ≥ 200 cells/µL. * Documented HIV-1 infection and screening plasma HIV-1 RNA ≥ 1 000 and ≤ 100 000 copies/mL. * Treatment-naïve. Prior use of o...
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VH4011499 is an investigational small molecule being developed for the treatment of HIV infections. It is a capsid inhibitor and is being studied as a long-acting injectable, including in combination with cabotegravir, in treatment-naive adults living with HIV. It is not yet approved for any use.
VH4011499 targets the HIV capsid protein, making it a capsid inhibitor. By acting on the capsid, the drug interferes with steps in the HIV replication cycle. It is being developed as a long-acting injectable formulation, which is the focus of its Phase 2b study in treatment-naive adults.
VH4011499 is being developed by GSK plc, which trades under the ticker GSK. GSK is running the clinical program for the drug, including a Phase 2b study of the long-acting injectable given with cabotegravir and several earlier-phase studies in healthy participants.
VH4011499 is in Phase 2 development. The lead study is a Phase 2b trial of the long-acting injectable plus cabotegravir in treatment-naive adults with HIV. Earlier Phase 1 studies have been completed, and the drug is investigational, meaning it has not been approved by the FDA.
VH4011499 has been studied in four trials. These include the Phase 2b CINERGY study, NCT07816250, in treatment-naive adults with HIV; a Phase 1 safety and pharmacokinetics study, NCT06724640; a completed food-effect study, NCT06368986; and a completed first-time-in-human study, NCT05393271.
Yes. VH4011499 low dose, VH4011499 Dose A, and VH4011499 low dose Injection are alternative names for the same investigational compound, VH4011499. These labels refer to dose levels or formulations of the drug rather than to a different asset, so searches using those terms point to the same GSK program.