Treatment of human immunodeficiency virus 1-infected infants and children with the protease inhibitor nelfinavir mesylate

An open-label study was conducted of nelfinavir mesylate, given with revers e transcriptase inhibitors to human immunodeficiency virus 1 (HIV-1)-infect ed infants and children 3 months to 13 years of age. Doses of nelfinavir me sylate of 20-30 mg/kg yielded drug exposures comparable to those seen in ad ults. The drug was well tolerated; mild diarrhea was the primary toxic effe ct observed. Seventy-one percent (39) of the 55 evaluable subjects had an i nitial decrease in plasma HIV-1 RNA, of at least 0.7 log(10) copies/mL; sup pression of plasma HIV-1 RNA levels to <400 copies/mL was observed in 15. C hildren who began taking at least one new reverse transcriptase inhibitor n ear the time when nelfinavir mesylate was started, and those with a greater than or equal to 24% proportion of CD4 lymphocytes, had a greater chance o f achieving and maintaining a decline in plasma HIV-1 RNA to <400 copies/mL . Suppression of viremia was achieved in children as young as 3 months of a ge.