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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
This study has been completed.
Sponsor:
Janssen, LP
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002159
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: December 1997
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Purpose
To assess the safety of intravenous itraconazole compared to amphotericin B in HIV positive or negative persons with blastomycosis or histoplasmosis.
| Condition | Intervention | Phase |
|---|---|---|
| HIV Infections Histoplasmosis Blastomycosis | Drug: Itraconazole Drug: Amphotericin B | Phase 3 |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by NIH AIDS Clinical Trials Information Service:
Eligibility| Ages Eligible for Study: | 13 Years and older (Child, Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002159
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002159
Locations
| 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 | |
Sponsors and Collaborators
Janssen, LP
More Information
| ClinicalTrials.gov Identifier: | NCT00002159 History of Changes |
| Other Study ID Numbers: |
254A ITR-USA-118 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
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 |
ClinicalTrials.gov processed this record on June 26, 2017