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JAC Advance Access originally published online on March 9, 2007
Journal of Antimicrobial Chemotherapy 2007 59(5):957-963; doi:10.1093/jac/dkm029
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© The Author 2007. 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

Exploratory study comparing the metabolic toxicities of a lopinavir/ritonavir plus saquinavir dual protease inhibitor regimen versus a lopinavir/ritonavir plus zidovudine/lamivudine nucleoside regimen

D. William Cameron1, Stephen Becker2,{dagger}, Martin S. King3, Barbara da Silva3, Cheri Klein3, Debbie Tokimoto3, Cheryl Foit3, Deborah Calhoun3, Barry Bernstein3,* and George J. Hanna3

1 University of Ottawa at The Ottawa Hospital, Box 228, 501 Smyth Rd., Ottawa, ON, Canada, K1H 8L6 2 Pacific Horizon Medical Group, 2351 Clay St. Suite 512, San Francisco, CA, 94115, USA 3 Abbott Laboratories, Dept. R48U, Bldg. AP30-3, 200 Abbott Park Road, Abbott Park, IL, 60064, USA

Received 12 October 2006; returned 18 December 2006; revised 12 January 2007; accepted 22 January 2007

* Correspondence address. Tel: +1-847-938-0013; Fax: +1-847-938-3711; E-mail: barry.bernstein{at}abbott.com

Objectives: To assess the safety, efficacy and metabolic toxicity of lopinavir/ritonavir + saquinavir or zidovudine/lamivudine and evaluate the pharmacokinetics of lopinavir/ritonavir + saquinavir.

Methods: HIV-1-infected, antiretroviral-naive subjects were randomized to lopinavir/ritonavir (400/100 mg) twice daily + saquinavir (800 mg) or zidovudine/lamivudine (150/300 mg) in a Phase II, 48 week study. Subjects receiving lopinavir/ritonavir + zidovudine/lamivudine initiated escalating doses of saquinavir (400, 600 and 800 mg) weekly for 3 weeks.

Results: By intent-to-treat (non-completer = failure) analysis, 10/16 (63%) lopinavir/ritonavir + saquinavir-treated and 7/14 (50%) lopinavir/ritonavir + zidovudine/lamivudine-treated subjects achieved plasma HIV-1 RNA <50 copies/mL (P = 0.713) at week 48. Safety, tolerability, metabolic changes and truncal fat increases were similar between groups. Small decreases in the lower extremity fat in the zidovudine/lamivudine group (–6%) and a statistically significant increase in the lower extremity fat in the saquinavir group (+19%) were observed. Lopinavir/ritonavir co-administered with saquinavir 600 or 800 mg twice daily produced saquinavir concentrations similar to those previously reported for saquinavir/ritonavir 1000/100 mg twice daily.

Conclusions: Treatment regimens had similar efficacy and tolerability. Metabolic parameters suggested lipoatrophy in the zidovudine/lamivudine treatment group. Saquinavir 600 and 800 mg twice daily produced concentrations similar to those previously reported for saquinavir/ritonavir 1000/100 mg twice daily.

Keywords: pharmacokinetics , lipoatrophy , HIV-1

{dagger} Present address. AnorMED, Inc., Suite 200 20353 64th Ave., Langley, BC, Canada, V2Y 1N5


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