P1090 is a phase I/II, multi-center, open-label, pharmacokinetic and safety study. The primary objectives are to evaluate the steady state pharmacokinetics of etravirine (ETR) in combination with an OBR in HIV-infected children aged ≥ 2 months to < 6 years; determine the safety and tolerability of etravirine in combination with an OBR in children aged ≥ 2 months to < 6 years, through 48 weeks of therapy and to determine the appropriate dose of etravirine in combination with an OBR for children aged ≥ 2 months to < 6 years. The study will accrue 50 subjects to yield 36 evaluable participants; duration of follow up is minimum of 48 weeks.

Main Objectives:
  1. To evaluate the steady state pharmacokinetics of etravirine in combination with an OBR in HIV-infected children aged ≥ 2 months to < 6 years.
  2. To determine the safety and tolerability of etravirine in combination with an OBR in children aged ≥ 2 months to < 6 years, through 48 weeks of therapy.
  3. To determine the appropriate dose of etravirine in combination with an OBR for children aged ≥ 2 months to < 6 years.

Pour plus d'information: IMPAACT Study P1090