Clinical Trial

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)

Active, Not Recruiting Phase 2
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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.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2024-12-17; most recent amendment 2025-11-14.
Status change: Recruiting → Active, Not Recruiting 2025-04-01
Status change: Not Yet Recruiting → Recruiting 2025-02-17
Trial Details
NCT Number NCT06741397
Lead Sponsor ViiV Healthcare
Conditions HIV Infections
Enrollment 229 participants
Start Date 2024-12-20
Primary Completion 2026-09-09 (estimated)
Study Completion 2029-01-10 (estimated)
Updated on ClinicalTrials.gov 2025-11-18