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Phase I/II Study of the Safety, Acceptability, Tolerability, and Pharmacokinetics of Oral and Long-Acting Injectable Cabotegravir and Long-Acting Injectable Rilpivirine in Virologically Suppressed HIV-Infected Children and Adolescents

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What is IMPAACT 2017 (MOCHA)?

IMPAACT 2017 is a Phase I/II, multi‐center, open‐label, non‐comparative study to confirm the dose and evaluate the safety, tolerability, acceptability, and PK of oral CAB, long-acting injectable CAB (CAB LA), and long-acting injectable RPV (RPV LA) among up to 155 virologically suppressed HIV‐1 infected children and adolescents aged 12 to <18 years. Up to 60 parents/caregivers of adolescent participants will also be enrolled to take part in in-depth qualitative interviews. The MOCHA study (More Options for Children and Adolescents) will enroll two sequential cohorts (Cohort 1 and Cohort 2), each with an oral lead-in phase followed by an injection phase. Cohort 1 will be followed for 16 weeks, whereas Cohort 2 will be followed for 96 weeks. Participants discontinuing study product injections will be followed for an additional 48 weeks to evaluate tolerability and acceptability, and characterize long-term safety and washout PK.

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