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Phase I/II Study of the Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less than 12 Years of Age

Study Status

Participants Off Study and Primary Analysis Completed

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IMPAACT 2019 is a Phase I/II open-label, multicenter, multiple dose study of dolutegravir/lamivudine/abacavir (Triumeq®) fixed dose combination tablets in treatment-experienced and treatment-naïve HIV-1-infected children less than 12 years of age. The study is designed to compare the pharmacokinetic exposure of dolutegravir, as contained in this pediatric formulation of Triumeq®, to exposures shown to be efficacious in adults. The study will also evaluate the safety and tolerability of this pediatric formulation over 48 weeks of treatment.

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