Back to Studies

IMPAACT 2036

Phase I/II Study of the Safety, Tolerability, Pharmacokinetics, and antiviral activity of Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in Virologically Suppressed HIV-Infected Children >2 to <12 years of age and weighing >10 kgs and <50 kgs

Study Status

In Development

Summary

IMPAACT 2036/CRAYON (Cabotegravir and Rilpivirine Long-Acting Injections in YOung ChildreN) is a Phase I/II, multi-center, open-label, non-comparative pharmacokinetic (PK) and safety study of cabotegravir (CAB) and rilpivirine (RPV) when taken orally (oral CAB + oral RPV) followed by long-acting injections (CAB LA + RPV LA) in virologically suppressed children living with HIV, aged 2 to less than 12 years of age and weighing 10kg to 50kg. The study is designed to determine the weight band dosing regimen and evaluate the safety, tolerability, PK, and antiviral activity of oral CAB + oral RPV followed by CAB LA + RPV LA. Two sequential cohorts will be enrolled and participants will be followed for 24 weeks (Cohort 1) and 72 weeks (Cohort 2) of study treatment.

Loading study documents...
Loading study sites...
Loading study protocol team...
Loading study press...
Loading study publications/presentations...