Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
VH3810109 · 3 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. 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, 2=Moderate, 3=Severe, 4=Potentially life threatening. This outcome measure is presenting only data for Grade 2 or more of severity.
An SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect or other situations as judged by physician.
ISRs were recorded via ISR diaries and managed through investigator assessment. The participants who experienced any injection site reaction were reported.
Liver chemistry stopping and increased monitoring criteria is analyzed using DAIDS AE Grading Table, where Grade 2 (moderate): causing greater than minimal interference with usual social and functional activities, Grade 3 (severe): causing inability to perform usual social and functional activities, Grade 4 (Potentially life threatening): causing inability to perform basic self-care functions or hospitalization indicated.
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. 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, 2=Moderate, 3=Severe, 4=Potentially life threatening. This outcome measure is presenting only data for Grade 2 or more of severity.
An SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect or other situations as judged by physician.
Liver chemistry stopping and increased monitoring criteria is analyzed using DAIDS AE Grading Table, where Grade 2 (moderate): causing greater than minimal interference with usual social and functional activities, Grade 3 (severe): causing inability to perform usual social and functional activities, Grade 4 (Potentially life threatening): causing inability to perform basic self-care functions or hospitalization indicated.
| Arm | Type | Description |
|---|---|---|
| Part 1A: Participants Receiving VH3810109 Formulation 1 plus Cabotegravir | EXPERIMENTAL | Participants will receive VH3810109 formulation 1 intravenously (IV) and Cabotegravir intramuscularly (IM) every month (QM). Participants from this arm will either transition to Part 2A or discontinue from the study and enter the LTFU period. |
| Part 1B: Participants Receiving VH3810109 plus rHuPH20 plus Cabotegravir | EXPERIMENTAL | Participants will receive VH3810109 plus rHuPH20 via subcutaneous (SC) infusion and Cabotegravir IM. This arm was discontinued following preliminary results. Participants from this arm will either transition to Part 1A at the next dosing visit or withdraw from the Investigational Product (IP) and enter the LTFU. |
| Part 1C: Participants Receiving SOC ART | ACTIVE_COMPARATOR | Participants in this arm will either transition to Part 2B or Part 2C or discontinue from the study. |
| Part 2A: Participants Receiving VH3810109 Formulation 2 plus Cabotegravir Q2M | EXPERIMENTAL | Participants will receive VH3810109 formulation 2 intravenously (IV) and Cabotegravir intramuscularly (IM) every 2 months (Q2M). Participants from this arm will either transition to Part 3A or discontinue from the study and enter the LTFU period. |
| Part 2B: Participants Receiving VH3810109 Formulation 2 plus Cabotegravir | EXPERIMENTAL | Participants will receive VH3810109 formulation 2 intravenously (IV) and Cabotegravir intramuscularly (IM) at Day 1, Month 1, Month 2 and then Q2M. Participants from this arm will either transition to Part 3A or discontinue from the study and enter the LTFU period. |
| Part 2C: Participants continuing SOC ART | ACTIVE_COMPARATOR | Participants in this arm will either transition to Part 3B or discontinue from the study. |
| Part 3A: Participants continuing VH3810109 Formulation 2 plus Cabotegravir Q2M | EXPERIMENTAL | Participants will continue to receive VH3810109 formulation 2 intravenously (IV) and Cabotegravir intramuscularly (IM) every 2 months (Q2M). |
| Part 3B: Participants receiving VH3810109 Formulation 2 plus Cabotegravir | EXPERIMENTAL | Participants will receive VH3810109 formulation 2 intravenously (IV) and Cabotegravir intramuscularly (IM) at Day 1, Month 1, Month 2 and then Q2M. |
| Participants receiving SOC INSTI-based ART in Randomized Intervention Phase (Step 1) | ACTIVE_COMPARATOR | - |
| Participants receiving SOC INSTI-based ART+VH3810109 in Randomized Intervention Phase (Step 1) | EXPERIMENTAL | - |
| Participants receiving SOC INSTI-based ART+VH3810109+FTR in Randomized Intervention Phase (Step 1) | EXPERIMENTAL | - |
| Participants receiving VH3810109 in ATI Phase (Step 2) | EXPERIMENTAL | - |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | EXPERIMENTAL | Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks. |
| Part 2 Group: VH3810109 60 mg/kg [IV] | EXPERIMENTAL | Participants in this group received a single intravenous (IV) dose of VH3810109 60 mg/kg at Day 1 and were followed up to 24 weeks. |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | EXPERIMENTAL | Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks. |
| Name | Type | Description |
|---|---|---|
| VH3810109 | BIOLOGICAL | VH3810109 will be administered. |
| Cabotegravir | DRUG | Cabotegravir will be administered. |
| Standard of care (SOC) | DRUG | Pre-baseline SOC antiretroviral therapy (ART) will be administered. |
| rHuPH20 | BIOLOGICAL | rHuPH20 will be administered. |
| Fostemsavir (FTR) | DRUG | Fostemsavir will be administered. |
| SOC INSTI-based ART | DRUG | A SOC INSTI-based ART regimen will be administered. |
Inclusion criteria Age 1. Participant must be 18 to 70 years of age inclusive, at the time of signing the informed consent. Type of Participant and Disease Characteristics 2. Must be on uninterrupted current regimen for at least 6 months prior to Screening. Any prior switch, defined as a chang...
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VH3810109 is an investigational monoclonal antibody being developed for the treatment of HIV infections. It is currently in Phase 2 clinical development, with studies evaluating its safety, pharmacokinetics, and virologic efficacy in people living with HIV.
VH3810109 is a monoclonal antibody designed to target HIV. It is being studied for its ability to reduce the size and activity of the viral reservoir in people living with HIV, as well as in combination with other antiretroviral agents.
VH3810109 is being developed by GSK plc, a global biopharma company listed on the London Stock Exchange under the ticker GSK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in HIV infections.
VH3810109 is currently in Phase 2 clinical development. It has completed a Phase 1 trial in healthy volunteers and is being evaluated in an ongoing Phase 2 study in adults living with HIV, as well as an additional Phase 1 study.
VH3810109 has been studied in three clinical trials. NCT05291520 was a completed Phase 1 study in healthy adults. NCT05996471 is an active Phase 2 trial comparing VH3810109 plus cabotegravir to standard of care. NCT07053384 is an active Phase 1 study evaluating VH3810109 with or without fostemsavir.
Yes, VH3810109 is also known as GSK3810109. The alternative name appears in the title of the Phase 1 clinical trial NCT05291520, which investigated the safety and pharmacokinetics of a single dose of VH3810109, also referred to as GSK3810109.