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JAC Advance Access originally published online on February 18, 2008
Journal of Antimicrobial Chemotherapy 2008 61(5):1145-1153; doi:10.1093/jac/dkn050
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© The Author 2008. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please e-mail: journals.permissions@oxfordjournals.org

Original research

Pharmacokinetics and short-term efficacy of a double-boosted protease inhibitor regimen in treatment-naive HIV-1-infected adults

Jasper van der Lugt1,2,*, Reshma Saskia Autar1,2, Sasiwimol Ubolyam1, Evian Fernandez Garcia2, Jongkol Sankote1, Anchalee Avihingson1, Theshinee Chuenyam1, David A. Cooper1,3, Joep Lange1,2,4, Praphan Phanuphak1,5, Ferdinand Wit2,4, Kiat Ruxrungtham1,5, David Burger on behalf of the HIV-NAT 019 Study Team6

1 HIV Netherlands Australia Thailand (HIV-NAT) Research Collaboration, Thai Red Cross AIDS Research Center Bangkok, 104 Ratchadamri Road, Pathumwan, Bangkok 10330, Thailand; 2 International Antiretroviral Therapy Evaluation Center, Pietersbergweg 9, 1105 BM Amsterdam, The Netherlands; 3 National Center in HIV Epidemiology and Clinical Research, University of New South Wales, Level 2, 376 Victoria Street, Darlinghurst, Sydney, NSW 2010, Australia; 4 Department of Internal Medicine, Academic Medical Center, University of Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands; 5 Department of Medicine, Faculty of Medicine, Chulalongkorn University, 104 Ratchadamri Road, Pathumwan, Bangkok 10330, Thailand; 6 Radboud University Nijmegen Medical Center, 864 Department of Clinical Pharmacy and Nijmegen University Centre for Infectious Diseases (NUCI), Geert Grooteplein 10, 6525 GA Nijmegen, The Netherlands

Received 6 November 2007; returned 5 December 2007; revised 27 December 2007; accepted 20 January 2008

* Correspondence address. HIV-NAT, Thai Red Cross AIDS Research Centre, 104 Rajdumri Road, Pathumwan, Bangkok 10330, Thailand. Tel: +66-2-652-3040, ext. 128; Fax: +66-2-254-7574/+66-2-252-5779; E-mail: jasper.v{at}hivnat.org

Objectives: To study the pharmacokinetics and short-term efficacy of low and standard dose lopinavir/ritonavir and saquinavir combinations in Thai, human immunodeficiency virus (HIV)-infected, treatment-naive patients.

Methods: In this open-label, 24-week, prospective study, 48 treatment-naive patients were randomized to lopinavir/ritonavir 400/100 mg+saquinavir 1000 mg twice daily (arm A), lopinavir/ritonavir 400/100 mg+saquinavir 600 mg twice daily (arm B), lopinavir/ritonavir 266/66 mg+saquinavir 1000 mg twice daily (arm C), or lopinavir/ritonavir 266/66 mg+saquinavir 600 mg twice daily (arm D). A 12 h. pharmacokinetic profile in all patients was performed. Plasma concentrations of saquinavir and lopinavir were determined using an HPLC technique. HIV-1 RNA was measured over 24 weeks.

Results: Forty-three subjects were included in the pharmacokinetic analysis. The total exposure differed significantly for the different arms. Median values for lopinavir area under the curve at 0–12 h were 128.2, 119.2, 66.1 and 68.5 mg·h/L for arms A–D, respectively. For saquinavir, the median values were 36.9, 19.2, 25.3 and 12.4 mg·h/L for arms A–D, respectively. The proportion of patients having a viral load below 50 copies/mL at week 24 was 39% for arm A, 63% for arm B, 55.0% for arm C, and 69% for arm D.

Conclusions: The pharmacokinetic parameters for the different treatment arms were adequate. However, the proportion of subjects with an undectable viral load at week 24 was lower than anticipated.

Keywords: viral dynamics , lopinavir , efficacy , dose reduction , saquinavir


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