Abstract
Introduction: Indinavir shows a high interindividual pharmacokinetic variability, and there is clinical evidence that therapeutic drug monitoring (TDM) may be useful to avoid its concentration-related adverse effects, such as hepatic and renal toxicity. Besides pharmacokinetic processes are affected by growth in children.
Objective: To evaluate results and importance of indinavir TDM in HIV pediatric patients receiving indinavir/ritonavir (r).
Methods: In a prospective study, 18 patients were evaluated. Indinavir plasma levels (1 trough and 1 peak, one hour after the dose) were measured by chromatography (HPLC). Average indinavir/r dose: 250/100 mg/m2/12hs. Therapeutic range proposed: 0.150 – 10 Yg/mL (adult patients)
Results: 11 patients (median: 38 months of treatment) had subtherapeutic levels (< 0.15 Yg/mL). In 6 patients, dose was increased to 400/100 mg/m2indinavir/r /12 h and a new monitoring was performed one month later. Of them, 2 remained with subtherapeutic levels.
Conclusions: pediatric dose of indinavir/r is not yet defined, but our data are close to previous works suggesting 400/125 mg/m2 indinavir/r / 12hs. Though indinavir is boosted by ritonavir, high variability observed in plasma levels suggests that indinavir TDM is advisable and could be useful to improve pediatric treatment, avoiding virological failure and occurrence of adverse events.
Article PDF
Author information
Authors and Affiliations
Rights and permissions
About this article
Cite this article
Cáceres, P., Currás, V., Bramuglia, G. et al. Therapeutic Drug Monitoring of Indinavir, Boosted with Ritonavir, in HIV Infected Pediatric Patients: TL005. Pediatr Res 60, 636 (2006). https://doi.org/10.1203/00006450-200611000-00025
Issue Date:
DOI: https://doi.org/10.1203/00006450-200611000-00025