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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Withdrawn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

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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