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Histoplasmosis |
Parasitic Infection, Histoplasmosis |
Clinical Trial: 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.
|
Purpose
To assess the safety of intravenous itraconazole compared to amphotericin B in HIV positive or negative persons with blastomycosis or histoplasmosis.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| HIV Infections Histoplasmosis Blastomycosis | Drug: Itraconazole Drug: Amphotericin B | Phase III |
MedlinePlus related topics: AIDS; Fungal Infections; Skin Diseases
Study Type: Interventional
Study Design: Treatment
Further Study Details:
Expected Total Enrollment: 60
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.
Eligibility
Ages Eligible for Study: 13 Years and above, Genders Eligible for Study: Both
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.
Location Information
Alabama
UAB Station / Infectious Division, Birmingham, Alabama, 35294, United States
Arkansas
Univ of Arkansas for Med Sciences, Little Rock, Arkansas, 72205, United States
Georgia
Division of Infectious Diseases, Atlanta, Georgia, 30303, United States
Indiana
Division of Inf Diseases/ Indiana Univ Hosp, Indianapolis, Indiana, 46202, United States
Community Hosp, Indianapolis, Indiana, 46218, United States
Louisiana
LSU Med Ctr / Div of Pulmonary & Critical Care Med, Shreveport, Louisiana, 71130, United States
Michigan
Ann Arbor Veterans Administration Med Ctr, Ann Arbor, Michigan, 48105, United States
Missouri
Infectious Diseases Association / Research Med Ctr, Kansas City, Missouri, 64132, United States
Univ of Missouri / Division of Infectious Diseases, Kansas City, Missouri, 641082792, United States
More Information
Study ID Numbers: 254A; ITR-USA-118
Record last reviewed: December 1997
Last Updated: October 13, 2004
Record first received: November 2, 1999
ClinicalTrials.gov Identifier: NCT00002159
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Record last reviewed: December 1997
Last Updated: October 13, 2004
Record first received: November 2, 1999
ClinicalTrials.gov Identifier: NCT00002159
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Histoplasmosis (National Women's Health Information Center)
- Histoplasmosis (Centers for Disease Control and Prevention (CDC))
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