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Controlled Clinical Trial
. 2008 Feb;83(2):300-6.
doi: 10.1038/sj.clpt.6100282. Epub 2007 Jul 4.

Pharmacokinetics and pharmacodynamics of efavirenz and nelfinavir in HIV-infected children participating in an area-under-the-curve controlled trial

C V Fletcher  1 , R C Brundage, T Fenton, C G Alvero, C Powell, L M Mofenson, S A Spector
Affiliations
Controlled Clinical Trial

Pharmacokinetics and pharmacodynamics of efavirenz and nelfinavir in HIV-infected children participating in an area-under-the-curve controlled trial

C V Fletcher et al. Clin Pharmacol Ther. 2008 Feb.

Abstract

Fifty human immunodeficiency virus (HIV)-infected children participated in an area-under-the plasma concentration-time curve (AUC)-controlled trial of efavirenz and nelfinavir. Pharmacokinetic evaluations were performed at weeks 2, 6, and 56. Efavirenz and nelfinavir doses were adjusted to achieve AUC values of 60-120 and > or = 10 mg h/l, respectively. Thirty-seven (74%) children met the efavirenz target and 41 (82%) the nelfinavir by week 10. Children with AUC values for both drugs above the first quartile were more likely to reach < 400 copies/ml of HIV RNA at week 8. Efavirenz and nelfinavir oral clearance increased 37 and 62% from weeks 2 to 56, respectively, in 34 children who continued on therapy at week 56. AUC values at week 56 were not different between children who did or did not have HIV RNA < 400 copies/ml. Dose adjustment to achieve specific AUC values in these children reduced the risk of suboptimal exposure and achieved high rates of virologic suppression.

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Conflict of interest statement

CONFLICT OF INTEREST

The authors declared no conflict of interest.

Figures

Figure 1
Figure 1
Box plot of efavirenz apparent oral clearance (CL/F, in l/h/kg) at weeks 2 and 56. CL/F at week 56 was significantly faster (P < 0.001, signed-rank test) than at week 2.
Figure 2
Figure 2
Box plot of nelfinavir apparent oral clearance (CL/F, in l/h/kg) at weeks 2 and 56. CL/F at week 56 was significantly faster (P < 0.001, signed-rank test) than at week 2.
See this image and copyright information in PMC

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