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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.
J Antimicrob Chemother. 2007 May; 59(5):957-63.JA

Abstract

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.

Authors+Show Affiliations

University of Ottawa at The Ottawa Hospital, Box 228, 501 Smyth Rd., Ottawa, ON, Canada, K1H 8L6.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase II
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

17350990

Citation

Cameron, D William, et al. "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." The Journal of Antimicrobial Chemotherapy, vol. 59, no. 5, 2007, pp. 957-63.
Cameron DW, Becker S, King MS, et al. 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. J Antimicrob Chemother. 2007;59(5):957-63.
Cameron, D. W., Becker, S., King, M. S., da Silva, B., Klein, C., Tokimoto, D., Foit, C., Calhoun, D., Bernstein, B., & Hanna, G. J. (2007). 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. The Journal of Antimicrobial Chemotherapy, 59(5), 957-63.
Cameron DW, et al. 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. J Antimicrob Chemother. 2007;59(5):957-63. PubMed PMID: 17350990.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Cameron,D William, AU - Becker,Stephen, AU - King,Martin S, AU - da Silva,Barbara, AU - Klein,Cheri, AU - Tokimoto,Debbie, AU - Foit,Cheryl, AU - Calhoun,Deborah, AU - Bernstein,Barry, AU - Hanna,George J, Y1 - 2007/03/09/ PY - 2007/3/14/pubmed PY - 2008/1/3/medline PY - 2007/3/14/entrez SP - 957 EP - 63 JF - The Journal of antimicrobial chemotherapy JO - J Antimicrob Chemother VL - 59 IS - 5 N2 - 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. SN - 0305-7453 UR - https://www.unboundmedicine.com/medline/citation/17350990/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_ L2 - https://academic.oup.com/jac/article-lookup/doi/10.1093/jac/dkm029 DB - PRIME DP - Unbound Medicine ER -