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) (NCT05996471)
A Phase 2b Multicenter, Randomized, Open-Label Study Comparing the Efficacy, Safety, PK, and Tolerability of VH3810109, Administered Either Intravenously Or As A Subcutaneous Infusion With rHuPH20, in Combination With CAB LA to Standard of Care in Virologically Suppressed Adults Living With HIV
🩺 Plain-English Summary (8th-Grade Level)
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).
Who can join: Review the eligibility criteria below.
Location: GSK Investigational Site — Birmingham, Alabama
Age range: 18 Years to 70 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (45 Sites)
Showing the first 25 of 45 sites.
- GSK Investigational Site — Birmingham, Alabama
- GSK Investigational Site — Bakersfield, California
- GSK Investigational Site — Los Angeles, California
- GSK Investigational Site — Los Angeles, California
- GSK Investigational Site — Palm Springs, California
- GSK Investigational Site — Sacramento, California
- GSK Investigational Site — San Francisco, California
- GSK Investigational Site — New Haven, Connecticut
- GSK Investigational Site — Washington D.C., District of Columbia
- GSK Investigational Site — Washington D.C., District of Columbia
- GSK Investigational Site — Fort Lauderdale, Florida
- GSK Investigational Site — Ft. Pierce, Florida
- GSK Investigational Site — Miami, Florida
- GSK Investigational Site — Orlando, Florida
- GSK Investigational Site — Pensacola, Florida
- GSK Investigational Site — Sarasota, Florida
- GSK Investigational Site — Vero Beach, Florida
- GSK Investigational Site — West Palm Beach, Florida
- GSK Investigational Site — Decatur, Georgia
- GSK Investigational Site — Chicago, Illinois
- GSK Investigational Site — Boston, Massachusetts
- GSK Investigational Site — Springfield, Massachusetts
- GSK Investigational Site — Southfield, Michigan
- GSK Investigational Site — Columbia, Missouri
- GSK Investigational Site — Newark, New Jersey
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.