An Open Study of the Effect of Itraconazole Oral Solution for the Treatment of Fluconazole Refractory Oropharyngeal Candidiasis in HIV-Positive Subjects.
NCT ID: NCT00002133
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
NONE
Interventions
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Itraconazole
Eligibility Criteria
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Inclusion Criteria
* HIV antibody seropositivity or diagnosis of AIDS.
* Confirmed oropharyngeal candidiasis.
* Failed fluconazole treatment within the past 14 days.
* Life expectancy of at least 3 months.
* NO symptoms of esophageal candidiasis (e.g., dysphagia) unless endoscopic exam of esophagus was performed and fungal esophagitis was not present.
* NO prior disseminated candidiasis.
Exclusion Criteria
Patients with the following symptoms or conditions are excluded:
* Underlying clinical condition that precludes study completion or places the patient at significant risk.
* Considered unreliable about following physician's directives.
Concurrent Medication:
Excluded:
* Investigational drugs (approved expanded access drugs are permitted).
* Rifampin.
* Rifabutin.
* Phenobarbital.
* Phenytoin.
* Carbamazepine.
* Terfenadine.
* Astemizole.
Patients with the following prior conditions are excluded:
* History of hypersensitivity to imidazole or azole compounds.
* Clinical evidence of significant hepatic disease within the past 2 months.
Prior Medication:
Excluded:
* Investigational drugs within 1 month prior to study entry (approved expanded access drugs are permitted).
18 Years
65 Years
ALL
No
Sponsors
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Janssen, LP
INDUSTRY
Locations
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Univ of Alabama at Birmingham
Birmingham, Alabama, United States
Univ of Arkansas for Med Sciences
Little Rock, Arkansas, United States
East Bay AIDS Ctr
Berkeley, California, United States
Kaiser Permanente Med Ctr
San Francisco, California, United States
Dr Douglas Ward
Washington D.C., District of Columbia, United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, United States
Veterans Administration Med Ctr
Washington D.C., District of Columbia, United States
Infectious Diseases Research Clinic / Indiana Univ Hosp
Indianapolis, Indiana, United States
Natl Inst of Allergy & Infect Dis / Cln Ctr
Bethesda, Maryland, United States
Ann Arbor Veterans Administration Med Ctr
Ann Arbor, Michigan, United States
Wayne State Univ / Harper Hosp
Detroit, Michigan, United States
Washington Univ
St Louis, Missouri, United States
Ohio State Univ Hosp
Columbus, Ohio, United States
Oklahoma City Veterans Administration Med Ctr
Oklahoma City, Oklahoma, United States
Pennsylvania Hosp
Philadelphia, Pennsylvania, United States
Infectious Disease Clinic
Nashville, Tennessee, United States
Audie L Murphy Veterans Administration Hosp
San Antonio, Texas, United States
Univ of Virginia Health Sciences Ctr
Charlottesville, Virginia, United States
Countries
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References
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Moskovitz B, Wu J, Baruch A, Benken C. Long term safety and efficacy of itraconazole oral solution (IS) for treatment of fluconazole refractory oropharyngeal candidiasis (OC) in HIV-positive patients (pts). Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:124 (abstract no 325)
Other Identifiers
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ITR-USA-94
Identifier Type: -
Identifier Source: secondary_id
236B
Identifier Type: -
Identifier Source: org_study_id