Overview

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.