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IMPAACT 2029
Phase I/II Study of Switching to Fixed Dose Combination Dolutegravir/Rilpivirine among Virologically Suppressed Children and Adolescents Living with HIV
Study Status
Withdrawn
DAIDS Number
38717
Primary Protocol Team Members
Summary
IMPAACT 2029 is a Phase I/II open-label, multicenter, non-comparative study of dolutegravir/rilpivirine (Juluca®) fixed dose combination tablets in treatment-experienced, virologically-suppressed children and adolescents (6 to less than 18 years of age) living with HIV. The study is designed to assess the pharmacokinetics of dolutegravir and rilpivirine among children and adolescents switching to the fixed dose combination tablets. The study will also evaluate safety, tolerability, acceptability, immunologic response, and virologic efficacy over 48 weeks of treatment.
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