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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen, LP
• Treatments: Amphotericin B; Hydroxyitraconazole; Itraconazole; Liposomal amphotericin B

Criteria

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.