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

Clin Infect Dis. 1999 May;28(5):1109-18. doi: 10.1086/514759.


An open-label study was conducted of nelfinavir mesylate, given with reverse transcriptase inhibitors to human immunodeficiency virus 1 (HIV-1)-infected infants and children 3 months to 13 years of age. Doses of nelfinavir mesylate of 20-30 mg/kg yielded drug exposures comparable to those seen in adults. The drug was well tolerated; mild diarrhea was the primary toxic effect observed. Seventy-one percent (39) of the 55 evaluable subjects had an initial decrease in plasma HIV-1 RNA, of at least 0.7 log10 copies/mL; suppression of plasma HIV-1 RNA levels to < 400 copies/mL was observed in 15. Children who began taking at least one new reverse transcriptase inhibitor near the time when nelfinavir mesylate was started, and those with a > or = 24% proportion of CD4 lymphocytes, had a greater chance of 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 age.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Anti-HIV Agents / therapeutic use
  • CD4 Lymphocyte Count / drug effects
  • Child
  • Child, Preschool
  • Drug Therapy, Combination
  • Female
  • HIV Infections / drug therapy*
  • HIV Protease Inhibitors / adverse effects
  • HIV Protease Inhibitors / pharmacokinetics
  • HIV Protease Inhibitors / therapeutic use*
  • HIV-1* / drug effects
  • HIV-1* / isolation & purification
  • Humans
  • Infant
  • Male
  • Nelfinavir / adverse effects
  • Nelfinavir / pharmacokinetics
  • Nelfinavir / therapeutic use*
  • RNA, Viral / blood
  • Reverse Transcriptase Inhibitors / therapeutic use


  • Anti-HIV Agents
  • HIV Protease Inhibitors
  • RNA, Viral
  • Reverse Transcriptase Inhibitors
  • Nelfinavir