Oral Posaconazole in High Risk Patients With Gastrointestinal Dysfunction (Study P05115)

Exclusion Criteria

• •Female subjects who are pregnant, intend to become pregnant, or are nursing.
• •Excluded prior treatments. Subjects receiving systemic antifungal therapy (oral, intravenous, or inhaled) for the treatment of proven or probable IFI within 30 days of Enrollment (ie, voriconazole, fluconazole \[FLU\], or itraconazole \[ITZ\]).
• •Subjects receiving posaconazole for prophylaxis against IFI 10 days prior to enrollment. (Subjects who are receiving either voriconazole or micafungin for prophylaxis against IFI should discontinue those therapies upon enrollment.)
• •Subjects with moderate or severe liver dysfunction at Baseline, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels greater than two times the upper limit of normal (ULN), or a total bilirubin level greater than two times the ULN.
• •Subjects who have taken prohibited medications more recently than the indicated washout period prior to Enrollment.
• •Subjects who must take prohibited medications during the study.
• •Subjects who are in a situation or have any condition that, in the opinion of the investigator, may interfere with optimal participation in the study.
• •Subjects who have used any investigational drugs or biologic agents other than their chemotherapy regimens within 30 days of study entry.
• •Subjects who are part of the staff personnel directly involved with this study.
• •Subjects who are a family member of the investigational study staff.
• •Prior enrollment in this study.
• •Subjects with a history of hypersensitivity or idiosyncratic reactions to azole agents.
• •Subjects with Eastern Cooperative Oncology Group (ECOG) performance status \>2 prior to induction chemotherapy for their underlying disease.
• •Subjects with proven or probable invasive or systemic fungal infection at Baseline.
• •Subjects with a history of acute lymphoblastic leukemia or chronic myelogenous leukemia without blast crisis.