Blastomycosis, Histoplasmosis, HIV Infections
Conditions
Keywords
Itraconazole, Histoplasmosis, Antifungal Agents, Acquired Immunodeficiency Syndrome, Amphotericin B, AIDS-Related Complex, Blastomycosis, Antibiotics, Antifungal
Brief summary
To assess the safety of intravenous itraconazole compared to amphotericin B in HIV positive or negative persons with blastomycosis or histoplasmosis.
Detailed description
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.
Interventions
DRUGItraconazole
DRUGAmphotericin B
Sponsors
Janssen, LP
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No
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.
Countries
United States
Outcome results
None listed