Randomized, Controlled, Double-Blind Study of Itraconazole Oral Solution Versus Fluconazole Tablets for the Treatment of Esophageal Candidiasis.
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Candidiasis, Esophageal; HIV Infections
Intervention: Itraconazole (Drug); Fluconazole (Drug)
Phase: N/A
Status: Completed
Sponsored by: Janssen, LP
Summary
To evaluate the safety and efficacy of itraconazole oral solution versus fluconazole tablets
for the treatment of esophageal candidiasis in immunocompromised patients.
Clinical Details
Official title: Randomized, Controlled, Double-Blind Study of Itraconazole Oral Solution Versus Fluconazole Tablets for the Treatment of Esophageal Candidiasis.
Study design: Treatment, Double-Blind, Safety Study
Eligibility
Minimum age: 13 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria
Patients must have:
- 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
Co-existing Condition:
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).
Locations and Contacts
Dr Eskild A Petersen, Tucson, Arizona 85724, United States
UCSD Med Ctr, San Diego, California 92103, United States
Los Angeles County - USC Med Ctr, Los Angeles, California 90033, United States
George Washington Univ Med Ctr, Washington, District of Columbia 20037, United States
Emory Univ School of Medicine, Atlanta, Georgia 30303, United States
Rush Presbyterian - Saint Luke's Med Ctr, Chicago, Illinois 60612, United States
Johns Hopkins Univ School of Medicine, Baltimore, Maryland 21205, United States
Wayne State Univ / Harper Hosp, Detroit, Michigan 48201, United States
Univ of Missouri at Kansas City School of Medicine, Kansas City, Missouri 64108, United States
Infectious Diseases Association / Research Med Ctr, Kansas City, Missouri 64132, United States
Montefiore Med Ctr, Bronx, New York 10467, United States
Dr Douglas Dieterich, New York, New York 10016, United States
Erie County Med Ctr, Buffalo, New York 14215, United States
Univ of North Carolina, Chapel Hill, North Carolina 27599, United States
Bowman Gray School of Medicine, Winston Salem, North Carolina 27157, United States
Univ Hosps of Cleveland, Cleveland, Ohio 44106, United States
Austin Infectious Disease Consultants, Austin, Texas 78705, United States
Houston Veterans Administration Med Ctr, Houston, Texas 77030, United States
Additional Information
Related publications: 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.
Last updated: June 23, 2005
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