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JAC Advance Access originally published online on March 28, 2003
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Journal of Antimicrobial Chemotherapy (2003) 51, 1231-1238
© 2003 The British Society for Antimicrobial Chemotherapy

Pharmacokinetics and pharmacodynamics of indinavir with or without low-dose ritonavir in HIV-infected Thai patients

David Burger1,*, Mark Boyd2,3, Chris Duncombe2,3, Mariet Felderhof4, Apicha Mahanontharit2, Kiat Ruxrungtham2, Sasiwimol Ubolyam2, Michael Stek5, David Cooper3, Joep Lange4, Praphan Phanupak2 and Peter Reiss4

1 Department of Clinical Pharmacy, 533 University Medical Centre Nijmegen, Geert Grooteplein 8, 6525 GA Nijmegen; 4 Academical Medical Centre/International AIDS Therapy Evaluation Centre, Amsterdam, The Netherlands; 2 HIV-NAT, Thai Red Cross AIDS Research Centre, Bangkok, Thailand; 3 National Centre in HIV Epidemiology and Clinical Research, Sydney, Australia; 5 Merck & Co., Whitehouse Station, NJ, USA

Received 13 January 2003; returned 27 January 2003; revised 7 February 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) mg×h/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) mg×h/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) mg×h/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

* Corresponding author. Tel: +31-24-3616405; Fax: +31-24-3540331; E-mail: D.Burger{at}akf.umcn.nl


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