Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05996471 | A Study to Investigate the Virologic Efficacy and Safety of VH3810109 + Cabotegravir Compared to Standard of Care (SOC) in Male and Female Adults Living With Human Immunodeficiency Virus (HIV) | PHASE2 | ACTIVE NOT_RECRUITING | 185 | — | — | Aug 17, 2023 | Nov 9, 2028 | Mar 11, 2026 | 45 | United States, Puerto Rico |
| NCT07053384 | A Study to Investigate the Use of VH3810109 With or Without Fostemsavir (FTR) to Reduce the Size and Activity of the Viral Reservoir in People Living With HIV | PHASE1 | ACTIVE NOT_RECRUITING | 107 | — | — | Jul 10, 2025 | Sep 6, 2028 | Mar 24, 2026 | 41 | United States, Belgium +4 |
| NCT05291520 | A Study to Investigate the Safety and Pharmacokinetics of a Single Dose of VH3810109 (Also Known as GSK3810109), Administered Either Subcutaneously (SC) With rHuPH20 or Intravenously (IV), in Healthy Adult Participants | PHASE1 | COMPLETED | 24 | — | — | Feb 23, 2022 | Apr 10, 2023 | Sep 19, 2024 | 1 | United States |
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 standard of care (SOC) integrase strand transfer inhibitor (INSTI)-based ART | ACTIVE_COMPARATOR | - |
| Participants receiving SOC INSTI-based ART plus VH3810109 | EXPERIMENTAL | - |
| Participants receiving SOC INSTI-based ART plus VH3810109 plus FTR | 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...