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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00004811
First Posted: February 25, 2000
Last Update Posted: June 9, 2006
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.
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
University of Alabama at Birmingham
Information provided by:
Office of Rare Diseases (ORD)
  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

Resource links provided by NLM:


Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment: 7
Study Start Date: March 1985
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.

  Eligibility

Information from the National Library of Medicine

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

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
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 ClinicalTrials.gov 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
Investigators
Study Chair: William Dismukes University of Alabama at Birmingham
  More Information

ClinicalTrials.gov Identifier: NCT00004811     History of Changes
Other Study ID Numbers: 199/12013
NIAID-MSG-6A
First Submitted: February 24, 2000
First Posted: February 25, 2000
Last Update Posted: June 9, 2006
Last Verified: December 2001

Keywords provided by Office of Rare Diseases (ORD):
blastomycosis
fungal infection
histoplasmosis
immunologic disorders and infectious disorders
rare disease
sporotrichosis

Additional relevant MeSH terms:
Histoplasmosis
Blastomycosis
Sporotrichosis
Mycoses
Dermatomycoses
Skin Diseases, Infectious
Infection
Lung Diseases, Fungal
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Skin Diseases
Itraconazole
Hydroxyitraconazole
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