A Safety & Effectiveness Study of Intravenous Anidulafungin With AmBisome® for Treatment of Invasive Aspergillosis (IA).

Inclusion criteria

• Diagnosis of definite IA outside the pulmonary system or definite or probable pulmonary IA
• Life expectancy: greater than 72 hours

Exclusion criteria

• Pregnant female
• Hypersensitivity to anidulafungin or echinocandin therapy
• Hypersensitivity to Tween 80 (polysorbate 80) or tartaric acid
• Hypersensitivity to amphotericin B deoxycholate or any other constituents of AmBisome unless, in the opinion of the investigator, the benefit of therapy outweighs the risk.
• Aspergilloma-in the absence of invasive disease
• Abnormal blood chemistries:

Bilirubin > 3 times the upper limit of normal; AST (aspartate aminotransferase) or ALT (alanine aminotransferase)> 5 times the upper limit of normal

• Greater than five days of therapeutic doses of systemic therapy for the current Aspergillus-associated condition or a cumulative dose of more than 5 mg/Kg of amphotericin, more than 25 mg/Kg of a lipid formulation of amphotericin, or more than 2g of itraconazole for the current condition. Prophylactic use of azoles or amphotericin is acceptable.
• Less than 4 weeks since prior participation in an investigational drug or device study, with the exception of cytotoxic, antiretroviral agents and therapies for AIDS-related opportunistic infections.