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Pharmacokinetics of nelfinavir in human immunodeficiency virus-infected infants

E V Capparelli1, J L Sullivan, L Mofenson

  • 1Department of Pediatrics, University of California, San Diego, La Jolla, CA, USA.

The Pediatric Infectious Disease Journal
|December 6, 2001
PubMed

Insights

Nelfinavir concentrations in infants are highly variable and lower than in older children or adults. Higher doses may be needed to ensure safety and effectiveness in infants under two years old.

Area of Science:

  • Pharmacology
  • Pediatric HIV Treatment

Background:

  • Nelfinavir dosing in older children approximates adult exposure.
  • Pharmacokinetics (PK) of nelfinavir in infants (< 2 years) is not well-described.

Purpose of the Study:

  • Determine the pharmacokinetics of nelfinavir in infants < 2 years of age.

Main Methods:

  • Evaluated nelfinavir concentrations in 22 HIV-infected infants (15 days to 2 years).
  • Nelfinavir was administered at ~25 mg/kg TID or ~55 mg/kg BID with other antiretrovirals.
  • PK samples collected predose, 1.5, and 4 hours postdose; intensive sampling at Week 1 for infants ≤ 3 months.

Main Results:

  • Median apparent clearance was 2.7 L/h/kg, similar between dosing frequencies.
  • Nelfinavir concentrations were lower in infants than in older pediatric patients.

Conclusions:

  • Infant nelfinavir concentrations are highly variable and lower than in adults/older children.
  • Further evaluation of nelfinavir safety, effectiveness, and PK at higher doses is necessary for infants.
Abstract

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