A Randomized, Open, Comparative Multicenter Study of Initial Treatment With Intravenous Itraconazole Versus Amphotericin B Followed by Consolidation Treatment With Itraconazole Capsules in Patients With Blastomycosis or Histoplasmosis

Official Title: “A Randomized, Open, Comparative Multicenter Study of Initial Treatment With Intravenous Itraconazole Versus Amphotericin B Followed by Consolidation Treatment With Itraconazole Capsules in Patients With Blastomycosis or Histoplasmosis”

To assess the safety of intravenous itraconazole compared to amphotericin B in HIV positive or negative persons with blastomycosis or histoplasmosis.

Patients are randomized to receive IV itraconazole for 2 days, then either itraconazole daily for 5 days or amphotericin B daily for 7 days. IV treatment is followed by consolidation with oral itraconazole for up to 1 year.

Intervention(s) in this Clinical Trial

• Drug: Itraconazole
• Drug: Amphotericin B

Inclusion Criteria

Patients must have:

• HIV positive or negative status.
• Blastomycosis or histoplasmosis.
• Life expectancy of at least 1 week.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Liver disease.
• Self-limiting fungal disease.
• Very severe fungal disease such as meningeal involvement.
• Acute respiratory disease.

Concurrent Medication:

Excluded at any time:

• Terfenadine.
• Astemizole.
• Oral midazolam.
• Triazolam.
• Cisapride.
• Phenytoin.
• Phenobarbital.
• Rifampin.
• Rifabutin.

Excluded during oral consolidation:

• H2 blockers.
• Chronic antacids.
• Omeprazole.
• Lansoprazole.

Patients with the following prior condition are excluded:

• Hypersensitivity to azole antifungals.

Prior Medication:

Excluded at any time:

• More than 3 days of amphotericin B, fluconazole, or ketoconazole.

Excluded within 2 weeks prior to study entry:

• Phenytoin.
• Phenobarbital.
• Rifampin.
• Rifabutin.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 13 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Janssen, LP Industry

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00002159

Study ID Number: 254A

ClinicalTrials.gov Identifier: NCT00002159

Health Authority: United States: Food and Drug Administration