An Open Label, Non-Comparative, Multi-Center Phase III Trial of the Efficacy, Safety, and Toleration of Extended Voriconazole in the Treatment of Invasive Fungal Infections

Date de début de l'étude : 1 décembre 1999

Males or (non-pregnant, lactating and nursing) females equal to or greater than 12 years of age. Previous enrollment into and completion of voriconazole therapy in protocol 99-C-0094 investigating the use of voriconazole in the treatment of invasive fungal disease or empirical treatment of presumed fungal infections and enrolled within three weeks of completion of 99-C-0094B. Clinical benefit was derived from previous voriconazole treatment. Further clinical benefit is expected with extended voriconazole treatment. Women of child bearing potential (or less than 2 years post- menopausal) must have a negative serum pregnancy test at baseline, and must agree to use barrier methods of contraception during the study. Signed written informed consent must be obtained at protocol entry. Assent will be obtained from minors capable of understanding. Subjects must not have either ongoing serious adverse events probably related to voriconazole therapy or have ongoing adverse events probably related to voriconazole therapy which may pose a significant risk on continued therapy. Must not have previously participated in this trial. If receiving, must be able to discontinue the following drugs at least 24 hours prior to randomization: terfenadine, cisapride, and astemizole. If receiving, must be able to discontinue sulphonylureas at least 24 hours prior to randomization. Must not have received the following drugs within 14 days prior to randomization: rifampin, carbamazepine, or barbiturates. Must not have AST, ALT, greater than 10 (upper limit normal). Must not have serum creatinine greater than 3.0 mg/dl.