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NCT06741397 · ClinicalTrials.gov registry record · Phase 2
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)
A Phase 2 study of HIV Infections, sponsored by ViiV Healthcare.
- Active
- Registry status
- Phase 2
- Development phase
- 229
- Enrollment target
- 20
- Study locations
NCT06741397: Active Phase 2 study of HIV Infections, sponsored by ViiV Healthcare.
NCT06741397 is a Phase 2 study of HIV Infections that is active but no longer recruiting, run by ViiV Healthcare. The registered enrollment target is 229 participants, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (49% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06741397, 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
- 229 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
CAB trough concentrations are evaluated at or above the target of 1.05 μg/mL for men and 1.39 μg/mL for women, once steady state has been achieved, but no earlier than Month 13 of the study.
Conditions Studied
Interventions
- DRUG CAB LA
- DRUG New formulation of CAB LA
Study Locations (20)
California
- GSK Investigational Site - Los Angeles
- GSK Investigational Site - Los Angeles
- GSK Investigational Site - Los Angeles
- GSK Investigational Site - Los Angeles
- GSK Investigational Site - Palm Springs
Florida
- GSK Investigational Site - Doral
- GSK Investigational Site - Ft. Pierce
- GSK Investigational Site - Orlando
- GSK Investigational Site - West Palm Beach
New York
- GSK Investigational Site - New York
- GSK Investigational Site - Valhalla
Alabama
- GSK Investigational Site - Birmingham
Illinois
- GSK Investigational Site - Chicago
Louisiana
- GSK Investigational Site - New Orleans
Massachusetts
- GSK Investigational Site - Springfield
Michigan
- GSK Investigational Site - Berkley
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 229 participants |
| Start Date | 2024-12-20 |
| Est. Completion | 2029-01-10 |
| Phase | Phase 2 |
What the registry record for NCT06741397 still lists
NCT06741397 is an interventional study that assigns participants to a tested intervention. The registered 229 participants enrollment target is mid-sized for trials with a published cap, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (49% lower).
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 2 interventions - of which CAB LA is the first listed.
NCT06741397 names 20 study sites across 12 states, led by California, Florida, New York.
Frequently Asked Questions
What is clinical trial NCT06741397 about?
NCT06741397 is a clinical study titled "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)". 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.
What is the current status of trial NCT06741397?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 229 participants. The study started on 2024-12-20. Estimated completion is 2029-01-10.
What conditions does trial NCT06741397 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT06741397?
The interventions under investigation include: CAB LA (DRUG), New formulation of CAB LA (DRUG).
Who is sponsoring clinical trial NCT06741397?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06741397 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Illinois, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06741397's enrollment target sits among peer trials
229 156th of 542 higher than 387 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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