A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a New Formulation of Cabotegravir Long-Acting Administered Intramuscularly in a 4-month Dosing Interval (Q4M) (NCT06741397)
A Phase 2b Single Arm, Repeat Dose Study to Evaluate the Pharmacokinetic Profile, Safety, and Tolerability of A New Formulation of Cabotegravir LA Injected Intramuscularly Q4M in Adolescent and Adult Participants at Risk of HIV Acquisition
๐ฉบ Plain-English Summary (8th-Grade Level)
This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a new formulation of Cabotegravir (CAB) dosed every 4-months (Q4M) for pre-exposure prophylaxis (PrEP) in participants at risk of HIV-1 acquisition.
Who can join: Review the eligibility criteria below.
Location: GSK Investigational Site โ Birmingham, Alabama
Age range: 16 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (27 Sites)
Showing the first 25 of 27 sites.
- GSK Investigational Site โ Birmingham, Alabama
- GSK Investigational Site โ Los Angeles, California
- GSK Investigational Site โ Los Angeles, California
- GSK Investigational Site โ Los Angeles, California
- GSK Investigational Site โ Los Angeles, California
- GSK Investigational Site โ Palm Springs, California
- GSK Investigational Site โ Doral, Florida
- GSK Investigational Site โ Ft. Pierce, Florida
- GSK Investigational Site โ Orlando, Florida
- GSK Investigational Site โ West Palm Beach, Florida
- GSK Investigational Site โ Chicago, Illinois
- GSK Investigational Site โ New Orleans, Louisiana
- GSK Investigational Site โ Springfield, Massachusetts
- GSK Investigational Site โ Berkley, Michigan
- GSK Investigational Site โ Kansas City, Missouri
- GSK Investigational Site โ Las Vegas, Nevada
- GSK Investigational Site โ New York, New York
- GSK Investigational Site โ Valhalla, New York
- GSK Investigational Site โ Greensboro, North Carolina
- GSK Investigational Site โ Cincinnati, Ohio
- GSK Investigational Site โ Columbus, Ohio
- GSK Investigational Site โ Pittsburgh, Pennsylvania
- GSK Investigational Site โ Dallas, Texas
- GSK Investigational Site โ Fort Worth, Texas
- GSK Investigational Site โ Seattle, Washington
๐ฐ 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 ยง 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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๐ก 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.