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
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ClinicalTrials.gov Identifier: NCT00002159 |
Recruitment Status
:
Completed
First Posted
: August 31, 2001
Last Update Posted
: June 24, 2005
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections Histoplasmosis Blastomycosis | Drug: Itraconazole Drug: Amphotericin B | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 60 participants |
Primary Purpose: | Treatment |
Official Title: | 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 |

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Ages Eligible for Study: | 13 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002159
United States, Alabama | |
UAB Station / Infectious Division | |
Birmingham, Alabama, United States, 35294 | |
United States, Arkansas | |
Univ of Arkansas for Med Sciences | |
Little Rock, Arkansas, United States, 72205 | |
United States, Georgia | |
Division of Infectious Diseases | |
Atlanta, Georgia, United States, 30303 | |
United States, Indiana | |
Division of Inf Diseases/ Indiana Univ Hosp | |
Indianapolis, Indiana, United States, 46202 | |
Community Hosp | |
Indianapolis, Indiana, United States, 46218 | |
United States, Louisiana | |
LSU Med Ctr / Div of Pulmonary & Critical Care Med | |
Shreveport, Louisiana, United States, 71130 | |
United States, Michigan | |
Ann Arbor Veterans Administration Med Ctr | |
Ann Arbor, Michigan, United States, 48105 | |
United States, Missouri | |
Univ of Missouri / Division of Infectious Diseases | |
Kansas City, Missouri, United States, 641082792 | |
Infectious Diseases Association / Research Med Ctr | |
Kansas City, Missouri, United States, 64132 |
ClinicalTrials.gov Identifier: | NCT00002159 History of Changes |
Other Study ID Numbers: |
254A ITR-USA-118 |
First Posted: | August 31, 2001 Key Record Dates |
Last Update Posted: | June 24, 2005 |
Last Verified: | December 1997 |
Keywords provided by NIH AIDS Clinical Trials Information Service:
Itraconazole Histoplasmosis Antifungal Agents Acquired Immunodeficiency Syndrome |
Amphotericin B AIDS-Related Complex Blastomycosis Antibiotics, Antifungal |
Additional relevant MeSH terms:
HIV Infections Histoplasmosis Blastomycosis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Mycoses Dermatomycoses Skin Diseases, Infectious Infection |
Lung Diseases, Fungal Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections Skin Diseases Itraconazole Hydroxyitraconazole Amphotericin B Liposomal amphotericin B Antifungal Agents Anti-Infective Agents 14-alpha Demethylase Inhibitors Cytochrome P-450 Enzyme Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |