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
Completed · Phase 3
Conditions studied: HIV Infections, Histoplasmosis, Blastomycosis
In brief
To assess the safety of intravenous itraconazole compared to amphotericin B in HIV positive or negative persons with blastomycosis or histoplasmosis.
Key facts
- Study ID
- NCT00002159
- Run by
- Janssen, LP
- People needed
- 60
- Last updated by the study team
- 2005-06-24
Who can join
Age: 13 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients must have:
- HIV positive or negative status.
- Blastomycosis or histoplasmosis.
- Life expectancy of at least 1 week.
You may not qualify if…
- 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:
Where it is running
- UAB Station / Infectious Division — Birmingham, Alabama, United States
- Univ of Arkansas for Med Sciences — Little Rock, Arkansas, United States
- Division of Infectious Diseases — Atlanta, Georgia, United States
- Division of Inf Diseases/ Indiana Univ Hosp — Indianapolis, Indiana, United States
- Community Hosp — Indianapolis, Indiana, United States
- LSU Med Ctr / Div of Pulmonary & Critical Care Med — Shreveport, Louisiana, United States
- Ann Arbor Veterans Administration Med Ctr — Ann Arbor, Michigan, United States
- Univ of Missouri / Division of Infectious Diseases — Kansas City, Missouri, United States
- Infectious Diseases Association / Research Med Ctr — Kansas City, Missouri, United States
Full record on ClinicalTrials.gov
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