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NCT05996471 · ClinicalTrials.gov registry record · Phase 2
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)
A Phase 2 study of HIV Infections, sponsored by ViiV Healthcare.
- Active
- Registry status
- Phase 2
- Development phase
- 185
- Enrollment target
- 20
- Study locations
NCT05996471: Active Phase 2 study of HIV Infections, sponsored by ViiV Healthcare.
NCT05996471 is a Phase 2 study of HIV Infections that is active but no longer recruiting, run by ViiV Healthcare. The registered enrollment target is 185 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (59% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05996471, a Phase 2 study of HIV Infections, is active but no longer recruiting, sponsored by ViiV Healthcare.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 185 participants
- Enrollment target
- 20
- Study locations
Study Summary
The study aims at evaluating the efficacy of VH3810109, dosed in accordance with the dosing schedule as either intravenous (IV) infusion or subcutaneous (SC) infusion with recombinant hyaluronidase (rHuPH20), in combination with cabotegravir (CAB) intramuscular (IM) dosed in accordance with the dosing schedule in virologically suppressed, Antiretroviral therapy (ART)-experienced adult participants living with HIV. VH3810109 plus rHuPH20 plus Cabotegravir arm of the study has been discontinued based on preliminary results. The study will be conducted in 3 parts followed by a Long-Term Follow-up phase (LTFU).
Conditions Studied
Interventions
- BIOLOGICAL VH3810109
- DRUG Cabotegravir
- DRUG Standard of care (SOC)
- BIOLOGICAL rHuPH20
Study Locations (20)
Florida
- GSK Investigational Site - Fort Lauderdale
- GSK Investigational Site - Ft. Pierce
- GSK Investigational Site - Miami
- GSK Investigational Site - Orlando
- GSK Investigational Site - Pensacola
- GSK Investigational Site - Sarasota
- GSK Investigational Site - Vero Beach
- GSK Investigational Site - West Palm Beach
California
- GSK Investigational Site - Bakersfield
- GSK Investigational Site - Los Angeles
- GSK Investigational Site - Los Angeles
- GSK Investigational Site - Palm Springs
- GSK Investigational Site - Sacramento
- GSK Investigational Site - San Francisco
District of Columbia
- GSK Investigational Site - Washington D.C.
- GSK Investigational Site - Washington D.C.
Alabama
- GSK Investigational Site - Birmingham
Connecticut
- GSK Investigational Site - New Haven
Georgia
- GSK Investigational Site - Decatur
Illinois
- GSK Investigational Site - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 185 participants |
| Start Date | 2023-08-17 |
| Est. Completion | 2028-11-09 |
| Phase | Phase 2 |
What the registry record for NCT05996471 still lists
NCT05996471 is an interventional study that assigns participants to a tested intervention. The registered 185 participants enrollment target is mid-sized for trials with a published cap, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (59% lower).
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 4 interventions - of which VH3810109 is the first listed.
NCT05996471 names 20 study sites across 7 states, led by Florida, California, District of Columbia.
Frequently Asked Questions
What is clinical trial NCT05996471 about?
NCT05996471 is a clinical study titled "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)". The study aims at evaluating the efficacy of VH3810109, dosed in accordance with the dosing schedule as either intravenous (IV) infusion or subcutaneous (SC) infusion with recombinant hyaluronidase (rHuPH20), in combination with cabotegravir (CAB) intramuscular (IM) dosed in accordance with the dosi...
What is the current status of trial NCT05996471?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 185 participants. The study started on 2023-08-17. Estimated completion is 2028-11-09.
What conditions does trial NCT05996471 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT05996471?
The interventions under investigation include: VH3810109 (BIOLOGICAL), Cabotegravir (DRUG), Standard of care (SOC) (DRUG), rHuPH20 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05996471?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05996471 being conducted?
This trial has 20 study locations across Alabama, California, Connecticut, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05996471's enrollment target sits among peer trials
185 187th of 542 higher than 356 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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