Phase I/II Study of Itraconazole for Blastomycosis, Histoplasmosis, and Sporotrichosis
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.
|Histoplasmosis Sporotrichosis Blastomycosis||Drug: itraconazole||Phase 1 Phase 2|
|Study Design:||Primary Purpose: Treatment|
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004811
|Study Chair:||William Dismukes||University of Alabama at Birmingham|