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P1090 / Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Etravirine

A Phase I/II, Open-Label Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Etravirine (ETR) in Antiretroviral Experienced HIV-1 Infected Infants and Children, Aged >= 2 Months to < 6 Years

Study Status

Participants Off Study and Primary Analysis Completed

DAIDS Number

10850

IND Number

113,895

Clinical Trials Link

Summary

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 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.

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