Pharmacokinetics, Safety, and Activity of Nevirapine in Human Immunodeficiency Virus Type 1-Infected Children

Phase I trials were conducted in human immunodeficiency virus type 1 (HIV-1)-infected children to examine the pharmacokinetics, safety, and antiretroviral activity of nevirapine, a nonnucleoside HIV-1 reverse transcriptase inhibitor. Nevirapine was rapidly absorbed, but the time to peak plasma concentrations increased with higher doses. Clearance was more rapid in chronic dosing studies than predicted by single-dose studies and was more rapid in younger children than in adolescent children. Rash, which occurred in 1 of the 21 study participants, was the single toxicity regarded as nevirapine-related, At doses ≥240 mg/rrrvday, 5 of 10 children experienced durable suppression of plasma p24 antigen to