Phase I/II Study of Itraconazole for Blastomycosis, Histoplasmosis, and Sporotrichosis
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Purpose
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 |
|---|---|---|
|
Histoplasmosis Sporotrichosis Blastomycosis |
Drug: itraconazole |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: 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.
Eligibility| 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
Contacts and Locations More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00004811 History of Changes |
| Other Study ID Numbers: | 199/12013, NIAID-MSG-6A |
| Study First Received: | February 24, 2000 |
| Last Updated: | June 8, 2006 |
| Health Authority: | United States: Federal Government |
Keywords provided by Office of Rare Diseases (ORD):
|
blastomycosis fungal infection histoplasmosis |
immunologic disorders and infectious disorders rare disease sporotrichosis |
Additional relevant MeSH terms:
|
Blastomycosis Histoplasmosis Sporotrichosis Dermatomycoses Skin Diseases, Infectious Infection Mycoses Skin Diseases Itraconazole |
Hydroxyitraconazole 14-alpha Demethylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antifungal Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013