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Phase I/II Study of Itraconazole for Blastomycosis, Histoplasmosis, and Sporotrichosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004811
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : June 9, 2006
National Institute of Allergy and Infectious Diseases (NIAID)
University of Alabama at Birmingham
Information provided by:
Office of Rare Diseases (ORD)

Brief Summary:

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 or disease Intervention/treatment Phase
Histoplasmosis Sporotrichosis Blastomycosis Drug: itraconazole Phase 1 Phase 2

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 7 participants
Primary Purpose: Treatment
Study Start Date : March 1985

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Histoplasmosis

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


--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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00004811

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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Study Chair: William Dismukes University of Alabama at Birmingham

Layout table for additonal information Identifier: NCT00004811     History of Changes
Other Study ID Numbers: 199/12013
First Posted: February 25, 2000    Key Record Dates
Last Update Posted: June 9, 2006
Last Verified: December 2001
Keywords provided by Office of Rare Diseases (ORD):
fungal infection
immunologic disorders and infectious disorders
rare disease
Additional relevant MeSH terms:
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Skin Diseases, Infectious
Lung Diseases, Fungal
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Skin Diseases
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors