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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

Study Status

Closed to Accrual

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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 children and adolescents aged 12 to <18 years with virologically suppressed HIV 1. Up to 60 parents/caregivers of U.S. adolescent 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). 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.

Participants who reach the end of Cohort 2 follow-up without confirmed access to the CAB LA + RPV LA regimen will transition into the Study Safety Extension. The Study Safety Extension will follow participants for up to an additional 48 weeks while further safety information is gathered. Participants will exit the study at the end of this 48 week period or once post-study access to the CAB LA + RPV LA regimen has been secured, whichever comes first.

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