Journal Article

Pharmacokinetics and Pharmacodynamics of Nelfinavir Administered Twice or Thrice Daily to Human Immunodeficiency Virus Type 1-Infected Children

G. Gatti, G. Castelli Gattinara, M. Cruciani, S. Bernardi, C. R. De Pascalis, E. Pontali, L. Papa, F. Miletich and D. Bassetti

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 36, issue 11, pages 1476-1482
Published in print June 2003 | ISSN: 1058-4838
Published online June 2003 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/375062
Pharmacokinetics and Pharmacodynamics of Nelfinavir Administered Twice or Thrice Daily to Human Immunodeficiency Virus Type 1-Infected Children

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We studied the pharmacokinetics and pharmacodynamics of nelfinavir administered 2 or 3 times per day to human immunodeficiency virus type 1 (HIV-1)-infected children receiving highly active antiretroviral therapy containing nelfinavir. The geometric mean trough concentrations of nelfinavir for the thrice- and twice-daily regimens were 1.55 mg/L and 1.11 mg/L, respectively (P = not significant). Nelfinavir concentrations did not correlate with total daily dose, dose per kilogram of weight, age, weight, previous protease inhibitor (PI) experience, or CD4+ cell percentage. In the 25 PI-naive children, the virus load reductions at 24 weeks of treatment with the twice- and thrice-daily regimens were comparable. A significantly higher percentage of children in the twice-daily group had a trough concentration of nelfinavir of less than the inhibitory concentration of 95% (P = .042). The decrease in the virus load at 24 weeks of treatment was not correlated with the trough concentration of nelfinavir. The variability of trough concentrations was extremely high, particularly among recipients of the twice-daily regimen, resulting in a higher number of patients with subinhibitory concentrations of nelfinavir in this group.

Journal Article.  3618 words.  Illustrated.

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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