P1093 is a Phase I/II, multi-center, open-label, non-comparative intensive pharmacokinetic and safety study of dolutegravir (GSK1349572) 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 a targeted AUC24 (primary PK endpoint) and C24h (secondary PK endpoint) in children and adolescents.

Main Objectives:
  1. To select a GSK1349572 dose for chronic dosing in infants, children and adolescents that achieves similar exposure to the GSK1349572 adult dose selected from the Phase IIb clinical trial in ART-naïve adult subjects.
  2. To determine the safety and tolerability of GSK1349572 in HIV-1 infected infants, children and adolescents at 24 and 48 weeks.
  3. To evaluate the steady-state pharmacokinetics of GSK1349572 in combination with other antiretrovirals (OBT) in treatment-experienced HIV-1 infected infants, children and adolescents and to determine the dose of GSK1349572 that achieves a targeted AUC24 (primary PK endpoint) and C24h (secondary PK endpoint) in this population.

For further information please refer to: IMPAACT Study P1093