drugset / Trial / NCT06741397

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

Phase 2 Active not recruiting 229 enrolled ViiV Healthcare
RandomizedSingle-groupOpen-labelOther

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.

Timeline

Start
2024-12-20
Primary completion
2026-09-09
Completion
2029-01-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Cabotegravir Small molecule Intramuscular