JAC Advance Access published online on March 28, 2003
Journal of Antimicrobial Chemotherapy, doi:10.1093/jac/dkg198
© 2003 by The British Society for Antimicrobial Chemotherapy
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Original Article
1 Department of Clinical
Pharmacy, 533 University Medical Centre Nijmegen, Geert Grooteplein
8, 6525 GA Nijmegen
* Corresponding author. E-mail: D.Burger{at}akf.umcn.nl.
Received 13 January 2003
; revised 27 January 2003
; accepted 9 February 2003
Objectives: To describe the pharmacokinetics
and pharmacodynamics of indinavir with or without low-dose ritonavir
in human immunodeficiency virus (HIV)-infected Thai patients. Patients and methods: Thirty-six HIV-1-infected
patients who participated in HIV-NAT 005 study gave informed consent
to record a pharmacokinetic curve 4 weeks after starting a regimen
containing either indinavir 800 mg every 8 h (n = 19)
or indinavir 800 mg + ritonavir 100 mg every 12 h (n = 17).
Indinavir plasma concentrations were measured by HPLC. Pharmacokinetic
parameters were calculated by non-compartmental methods. Results: The median (interquartile range; IQR)
body weight of the 36 patients (11 females and 25 males) was 60
(54-72) kg. Median and IQR values for indinavir AUC, Cmax and Cmin were
20.9 (13.1-27.0) mgxh/L, 8.1 (6.6-9.4) mg/L and
0.13 (0.09-0.27) mg/L, respectively, for indinavir
800 mg every 8 h, and 49.2 (42.5-60.4) mgxh/L, 10.6
(8.5-13.2) mg/L and 0.68 (0.43-0.77) mg/L, respectively,
for indinavir 800 mg + ritonavir 100 mg every 12 h. These
values are not largely different from values found in Caucasian
patients, with the exception of relatively high peak levels of indinavir
in Thai subjects. Cut-off values for optimal virological efficacy
were an indinavir Cmin of 0.10 and 0.25
mg/L for the every 8 h and the every 12 h regimen, respectively;
patients with an indinavir AUC greater than 30 (every 8 h regimen)
or 60 (every 12 h regimen) mgxh/L were at increased risk of developing
nephrotoxicity. Conclusions: Indinavir pharmacokinetics and
pharmacodynamics in Thai HIV-1-infected patients are similar to
those described in Caucasian patients, despite an overall lower
body weight in this population
Keywords: HIV, protease inhibitors, Thailand
Pharmacokinetics and pharmacodynamics of indinavir
with or without low-dose ritonavir in HIV-infected Thai patients
2 HIV-NAT,
Thai Red Cross AIDS Research Centre, Bangkok, Thailand; National Centre in HIV Epidemiology
and Clinical Research, Sydney, Australia
3 Academical
Medical Centre/International AIDS Therapy Evaluation Centre, Amsterdam,
The Netherlands
4 HIV-NAT,
Thai Red Cross AIDS Research Centre, Bangkok, Thailand
5 Merck & Co., Whitehouse Station, NJ, USA
6 National Centre in HIV Epidemiology
and Clinical Research, Sydney, Australia
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