Randomized, Controlled, Double-Blind Study of Itraconazole Oral Solution Versus Fluconazole Tablets for the Treatment of Esophageal Candidiasis.
NCT ID: NCT00002132
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
DOUBLE
Interventions
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Itraconazole
Fluconazole
Eligibility Criteria
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Inclusion Criteria
* Esophageal candidiasis.
* Histological evidence of Candida spp. at baseline with confirmation by positive mycological culture.
* HIV infection or other predisposing risk factor.
* Life expectancy of at least 2 months.
Exclusion Criteria
Patients with the following symptoms or conditions are excluded:
* Malignancies of the head or neck, if the treatment or disease will interfere with response assessment.
* Evidence of systemic fungal infection.
* Underlying clinical condition that would preclude study completion.
* Judged to be unreliable in regard to following physician's directives.
Concurrent Medication:
Excluded:
* Rifampin.
* Rifabutin.
* Phenobarbital.
* Phenytoin.
* Carbamazepine.
* Terfenadine.
* Astemizole.
* H2 blockers.
* Continual antacids.
* Any investigational drug (expanded access drugs are allowed).
Patients with the following prior conditions are excluded:
* History of significant hepatic abnormalities or clinical evidence of hepatic disease within 2 months prior to study entry.
* History of hypersensitivity to imidazole or azole compounds.
Prior Medication:
Excluded:
* Other orally administered antifungal therapy within 3 days prior to study entry.
* Any investigational drug within 1 month prior to study entry (expanded access drugs are allowed).
13 Years
ALL
No
Sponsors
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Janssen Pharmaceuticals
INDUSTRY
Locations
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Dr Eskild A Petersen
Tucson, Arizona, United States
Los Angeles County - USC Med Ctr
Los Angeles, California, United States
UCSD Med Ctr
San Diego, California, United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, United States
Emory Univ School of Medicine
Atlanta, Georgia, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States
Johns Hopkins Univ School of Medicine
Baltimore, Maryland, United States
Wayne State Univ / Harper Hosp
Detroit, Michigan, United States
Univ of Missouri at Kansas City School of Medicine
Kansas City, Missouri, United States
Infectious Diseases Association / Research Med Ctr
Kansas City, Missouri, United States
Erie County Med Ctr
Buffalo, New York, United States
Dr Douglas Dieterich
New York, New York, United States
Montefiore Med Ctr
The Bronx, New York, United States
Univ of North Carolina
Chapel Hill, North Carolina, United States
Bowman Gray School of Medicine
Winston-Salem, North Carolina, United States
Univ Hosps of Cleveland
Cleveland, Ohio, United States
Austin Infectious Disease Consultants
Austin, Texas, United States
Houston Veterans Administration Med Ctr
Houston, Texas, United States
Countries
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References
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Barbaro G, Barbarini G, Di Lorenzo G. Fluconazole compared with itraconazole in the treatment of esophageal candidiasis in AIDS patients: a double-blind, randomized, controlled clinical study. Scand J Infect Dis. 1995;27(6):613-7. doi: 10.3109/00365549509047076.
Other Identifiers
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ITR-USA-12
Identifier Type: -
Identifier Source: secondary_id
236A
Identifier Type: -
Identifier Source: org_study_id