Histoplasmosis Clinical Trial
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.
;
Primary Purpose: Treatment
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