Histoplasmosis Clinical Trial
OBJECTIVES: I. Identify a preferred oral fluconazole dose regimen for patients with
non-acute histoplasmosis or blastomycosis, or ulcerocutaneous or deep sporotrichosis.
II. Study the safety and efficacy of fluconazole in these patients.
PROTOCOL OUTLINE: This is a randomized study. Patients are stratified by participating
institution and type of infection.
Patients with blastomycosis are randomly assigned to moderate- versus high-dose oral
fluconazole. Based on clinical response, the dose is increased at 1 and 2 months for
patients in the moderate-dose group. Patients in the high-dose group receive a fixed dose of
fluconazole.
Patients with histoplasmosis and sporotrichosis are nonrandomly treated with moderate-dose
fluconazole.
Therapy is administered daily for 3 months beyond stabilization of infection (maximum 24
months), or for a total of 6 months if the infection stabilizes within 3 months. Fluconazole
may be administered intravenously (maximum 7 days) if the oral dose is not tolerated.
Concurrent systemic or intrathecal antifungals, immunostimulants, and lymphocyte replacement
are prohibited. Investigational agents or approved agents given for investigational
indications are also not permitted on study.
Patients are followed at 3, 6, and 12 months.
;
Primary Purpose: Treatment
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