Study Status
Participants Off Study and Primary Analysis Completed
DAIDS Number
38504
IND Number
141131
Clinical Trials Link
Primary Protocol Team Members
Summary
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.