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Phase I/II Study of Itraconazole for Blastomycosis, Histoplasmosis, and Sporotrichosis

This study has been completed.
Sponsor:
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
University of Alabama at Birmingham
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00004811
First received: February 24, 2000
Last updated: June 8, 2006
Last verified: December 2001
History of Changes

February 24, 2000
June 8, 2006
March 1985
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Complete list of historical versions of study NCT00004811 on ClinicalTrials.gov Archive Site
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Phase I/II Study of Itraconazole for Blastomycosis, Histoplasmosis, and Sporotrichosis
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OBJECTIVES: I. Evaluate the tolerance of patients with blastomycosis, histoplasmosis, and sporotrichosis to different doses of itraconazole (R51,211).

II. Determine levels of itraconazole in serum and other body fluids. III. Assess the course of illness during itraconazole therapy. IV. Determine the dosage of itraconazole that is safe and well tolerated by 80%-90% of patients and estimate the potential of this dosage for use in future comparative trials.

PROTOCOL OUTLINE: This is a study to estimate the optimal dose of oral itraconazole. Patients are treated at 1 of 3 doses of itraconazole; the starting dose for each patient is determined at entry.

Therapy is administered daily for 3-6 months. Patients with progressive disease may be treated at the next higher dose; there may be only 1 such increase. Concurrent systemic and topical antifungals are prohibited.

Patients are followed at 1, 3, 6, and 12 months.
Interventional
Phase 1
Phase 2
Primary Purpose: Treatment
  • Histoplasmosis
  • Sporotrichosis
  • Blastomycosis
Drug: itraconazole
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
7
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PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Culture-proven fungal disease, i.e.: Chronic cavitary histoplasmosis Extrapulmonary histoplasmosis, e.g., mucosal disease Blastomycosis Sporotrichosis Positive culture after last dose of any prior therapy Requires antifungal therapy with amphotericin B or ketoconazole No fungal meningitis No central nervous system disease No immediately life-threatening disease --Prior/Concurrent Therapy-- At least 1 month since therapy for same disease No more than 2 mg/kg prior amphotericin B (total dose) No more than 2 mg/kg prior ketoconazole (total dose) No concurrent immunosuppressives, including: Corticosteroids Azathioprine Cytotoxic agents --Patient Characteristics-- Hepatic: AST no greater than 3 times normal Alkaline phosphatase no greater than 3 times normal Bilirubin no greater than 3 mg/dL Other: No acquired immunodeficiency syndrome No pregnant or nursing women Effective contraception required of fertile women
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT00004811
199/12013, NIAID-MSG-6A
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National Center for Research Resources (NCRR)
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • University of Alabama at Birmingham
Study Chair: William Dismukes University of Alabama at Birmingham
Office of Rare Diseases (ORD)
December 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP