๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-11-14

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

๐Ÿ”ต Active, Not Recruiting Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: ViiV Healthcare

๐Ÿฉบ 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

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ 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

๐Ÿ’ฐ 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.

Explore by condition: All HIV Infections clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—