Study Title: Phase I/II, Multi-Center, Open-Label Pharmacokinetic, Safety, Tolerability and Antiviral Activity of Dolutegravir, a Novel Integrase Inhibitor, in Combination Regimens in HIV-1 Infected Infants, Children and Adolescents
P1093 is a Phase I/II, multi-center, open-label, non-comparative intensive pharmacokinetic and safety study of dolutegravir in combination regimens in HIV-1 infected infants, children and adolescents. The primary objectives of the study are to select a dolutegravir dose for chronic dosing; to determine the safety and tolerability of the dose, to evaluate the steady-state pharmacokinetics of dolutegravir in combination with other antiretrovirals and to determine the dose of dolutegravir that achieves the targeted C24h and AUC0-24 PK parameters in the population. The study is closed to accrual.
Location: HFC CRS