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Home > "P" Clinical Trials Conditions > Phase I/II Study of Itraconazole for Blastomycosis, Histoplasmosis, and Sporotrichosis  Phase I/II Study of Itraconazole for Blastomycosis, Histoplasmosis, and Sporotrichosis
Phase I/II Study of Itraconazole for Blastomycosis, Histoplasmosis, and Sporotrichosis
For Condition: Sporotrichosis,Blastomycosis,Histoplasmosis
Status: Completed
Sponsor(s): National Center for Research Resources (NCRR) , National Institute of Allergy and Infectious Diseases (NIAID),University of Alabama
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment: 7
Location and Contact Information:
Overall Study Official:
WilliamDismukes, Study Chair, University of Alabama
Additional Information:
Study ID Numbers: 199/12013; NIAID-MSG-6A
Study Start Date: March 1985
Record last reviewed: December 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004811
Other Histoplasmosis Studies:
1. Phase II Study of Fluconazole for Lymphocutaneous and Visceral Sporotrichosis
2. Phase II Pilot Study of Fluconazole for Histoplasmosis, Blastomycosis, and Sporotrichosis
3. Phase I/II Study of Itraconazole for Blastomycosis, Histoplasmosis, and Sporotrichosis
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Phase I/II Study of Itraconazole for Blastomycosis, Histoplasmosis, and Sporotrichosis
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