- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002159
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment
Phase
- Phase 3
Contacts and Locations
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35294
- UAB Station / Infectious Division
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Arkansas
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Little Rock, Arkansas, United States, 72205
- Univ of Arkansas for Med Sciences
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Georgia
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Atlanta, Georgia, United States, 30303
- Division of Infectious Diseases
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Indiana
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Indianapolis, Indiana, United States, 46202
- Division of Inf Diseases/ Indiana Univ Hosp
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Indianapolis, Indiana, United States, 46218
- Community Hosp
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Louisiana
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Shreveport, Louisiana, United States, 71130
- LSU Med Ctr / Div of Pulmonary & Critical Care Med
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Michigan
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Ann Arbor, Michigan, United States, 48105
- Ann Arbor Veterans Administration Med Ctr
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Missouri
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Kansas City, Missouri, United States, 64132
- Infectious Diseases Association / Research Med Ctr
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Kansas City, Missouri, United States, 641082792
- Univ of Missouri / Division of Infectious Diseases
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Lung Diseases
- Bacterial Infections and Mycoses
- Skin Diseases, Infectious
- Mycoses
- Dermatomycoses
- Lung Diseases, Fungal
- Histoplasmosis
- Blastomycosis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Anti-Bacterial Agents
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Hormone Antagonists
- Antifungal Agents
- Steroid Synthesis Inhibitors
- Antiprotozoal Agents
- Antiparasitic Agents
- Amebicides
- 14-alpha Demethylase Inhibitors
- Itraconazole
- Amphotericin B
- Liposomal amphotericin B
Other Study ID Numbers
- 254A
- ITR-USA-118
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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