Voriconazole to Treat Fungal Infections

Inclusion Criteria

• •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.