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Sponsors and Collaborators: |
National Center for Research Resources (NCRR) National Institute of Allergy and Infectious Diseases (NIAID) University of Alabama at Birmingham |
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Information provided by: | Office of Rare Diseases (ORD) |
ClinicalTrials.gov Identifier: | NCT00004811 |
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.
Condition | Intervention | Phase |
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Histoplasmosis Sporotrichosis Blastomycosis |
Drug: itraconazole |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Estimated Enrollment: | 7 |
Study Start Date: | March 1985 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
Study ID Numbers: | 199/12013, NIAID-MSG-6A |
Study First Received: | February 24, 2000 |
Last Updated: | June 8, 2006 |
ClinicalTrials.gov Identifier: | NCT00004811 |
Health Authority: | United States: Federal Government |
blastomycosis fungal infection histoplasmosis |
immunologic disorders and infectious disorders rare disease sporotrichosis |
Skin Diseases Clotrimazole Blastomycosis Miconazole Histoplasmosis Rare Diseases Tioconazole |
Itraconazole Hydroxyitraconazole Mycoses Skin Diseases, Infectious Sporotrichosis Dermatomycoses |
Anti-Infective Agents Antiparasitic Agents Antiprotozoal Agents Therapeutic Uses |
Antifungal Agents Infection Pharmacologic Actions |