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Objective   The pharmacokinetics of 800 mg and 1200 mg of saquinavir soft-gel caps (SQV-SGC) twice daily plus 100 mg itraconazole once daily were compared to 1400 mg SQV-SGC twice daily without itraconazole.Methods   The pharmacokinetics of SQV were determined in 17 randomly selected patients on 1400 mg twice daily SQV-SGC without itraconazole and after 2 weeks with lower SQV-SGC doses plus itraconazole. SQV plasma concentrations were determined by HPLC. Pharmacokinetic parameters were calculated by a non-compartmental model.Results   Median (+IQR) area under plasma concentration-versus-time curve (AUC 0–12h ) were 3.33 (1.96–7.34), 4.29 (3.14–7.67) and 4.07 (2.76–4.49) mg/l.h for SQV 1400 mg without itraconazole, SQV 1200 mg with itraconazole and SQV 800 mg with itraconazole, respectively. These differences were not statistically significant. The median C min  was above the proposed minimum effective concentration of 0.05 mg/l for all three regimens.Conclusion   SQV-SGC 800 mg or 1200 mg twice daily boosted with 100 mg of itraconazole once daily resulted in adequate SQV pharmacokinetics not significantly different from SQV-SGC 1400 mg twice daily.

Pharmacokinetics of Lower Doses of Saquinavir Soft-Gel Caps (800 and 1200 Mg Twice Daily) Boosted with Itraconazole in HIV-1-Positive Patients