A Study of the Safety and Efficacy of Posaconazole Versus Voriconazole for the Treatment of Invasive Aspergillosis (MK-5592-069 AM1)

Inclusion Criteria:

• Weight >40 kg (88 lb) and ≤150 kg (330 lb) for participants ≥13 years of age and ≥50 kg (110 lb) for participants between 13 and 14 years of age.
• Acute IA defined as duration of clinical syndrome of <30 days.
• Female subjects of child-bearing potential must be using a medically accepted method of birth control before beginning study-drug treatment and agree to continue its use for 30 days after stopping study medication.

Exclusion Criteria:

• Chronic (>1 month duration) IA, relapsed/recurrent IA, or refractory IA which has not responded to antifungal therapy.
• Sarcoidosis, aspergilloma, or allergic bronchopulmonary aspergillosis (ABPA).
• Known mixed invasive mold fungal infection including Zygomycetes, and/or a known invasive Aspergillus fungal infection in which either study drug may not be considered active.
• Receipt of any systemic (oral, intravenous, or inhaled) antifungal therapy for this infection episode for 4 or more consecutive days immediately before randomization.
• Taking mold-active antifungal prophylaxis and the infection is considered to be a breakthrough (i.e., IA infection that develops after the initiation of 13 days or more of preventative mold-active systemic antifungal therapy).
• Receipt of posaconazole or voriconazole as empirical treatment for this infection for 4 days (96 hours) or more within the 15 days immediately before randomization.
• Known hypersensitivity or other serious adverse reaction to any azole antifungal therapy.
• Females who are pregnant, intend to become pregnant, or are nursing at the time of randomization.
• Known history of Torsade de Pointes, unstable cardiac arrhythmia or proarrhythmic conditions, or a history of recent myocardial infarction within 90 days of study entry.
• Hepatic cirrhosis or a Child-Pugh score of C (severe hepatic impairment) at the time of randomization.
• Severe renal insufficiency (estimated creatinine clearance <20 mL/min) or on hemodialysis at the time of randomization or likely to require dialysis during the study.
• Known hereditary problem of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
• Acute symptomatic pancreatitis within 6 months of study entry or a diagnosis of chronic pancreatitis at the time of randomization.
• Active skin lesion consistent with squamous cell carcinoma or melanoma at the time of randomization or history of malignant melanoma within 5 years of study entry.
• On artificial ventilation at the time of randomization.
• Known or suspected Gilbert's disease at the time of randomization.
• Requires treatment with other medications that cannot be stopped and for which there is a known contraindication to co-administration of one or more of the study drugs.