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Phase I/II Study of the Safety, Tolerability, Acceptability, and Pharmacokinetics of Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in Virologically Suppressed Children Living with HIV-1, Two to Less Than 12 Years of Age

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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.

Site selection was completed in December 2021. IMPAACT sites located in a country where the pharmaceutical partner has plans for licensure of the study product were invited to participate. Planned sites are located in Botswana, Brazil, South Africa, Thailand, Uganda, and the United States.

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