To determine the safety, toleration, and efficacy of fluconazole oral suspension in the treatment of esophageal candidiasis in immunocompromised patients, including those with AIDS...
Date First Received: November 2, 1999
Last Updated: June 23, 2005
Verified by: NIH AIDS Clinical Trials Information Service, April 1996
Clinical Trial Phase: Phase 3 | Start Date:
Overall Status: Completed
Estimated Enrollment: 100
Brief Summary
Official Title: “An Open Multicenter Trial of Fluconazole Oral Suspension in the Treatment of Esophageal Candidiasis in Immunocompromised Patients”
Condition Keyword(s):
Intervention(s):
To determine the safety, toleration, and efficacy of fluconazole oral suspension in the treatment of esophageal candidiasis in immunocompromised patients, including those with AIDS.
Study Type: Interventional
Study Design: Treatment, Safety Study
Detailed Clinical Trial Description
Patients receive fluconazole oral suspension for a minimum of 3 weeks and maximum of 8 weeks.
Patients are evaluated weekly, and treatment continues for 2 weeks after resolution of symptoms. Endoscopic exams and possibly biopsies are performed at baseline and at the end of treatment. Patients undergo follow-up at 2 weeks post-treatment.
Intervention(s) in this Clinical Trial
- Drug: Fluconazole
Criteria for Participation in this Clinical Trial
Inclusion Criteria
Patients must have:
- AIDS or other immunocompromising condition.
- Candidal esophagitis.
- Life expectancy of at least 2 months.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
- Evidence of non-candidal systemic fungal infection.
- Abnormalities that may preclude esophagoscopy or endoscopy.
- Unable to tolerate fluconazole.
- Unable to give informed consent.
- Enrollment in other experimental trials of approved or non-approved drugs or systemic compounds (unless approved by the Pfizer Clinical Monitor).
- Other condition that would make patient unsuitable for enrollment.
Concurrent Medication:
Excluded:
- Concomitant oral or topical antifungal agent.
- Other experimental medications.
Patients with the following prior condition are excluded:
- History of allergy to imidazoles or azoles.
Prior Medication:
Excluded:
- Any oral or topical antifungal therapy within the past 3 days. Active use of illicit or illegal drugs.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 13 Years
Maximum Age for this Clinical Trial: 70 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Pfizer
Related Publications
References
Agresti MG, de Bernardis F, Mondello F, Bellocco R, Carosi GP, Caputo RM, Milazzo F, Chiodo F, Giannini V, Minoli L, et al. Clinical and mycological evaluation of fluconazole in the secondary prophylaxis of esophageal candidiasis in AIDS patients. An open, multicenter study. Eur J Epidemiol. 1994 Feb;10(1):17-22.
Additional Information
Information obtained from ClinicalTrials.gov on November 18, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00002339
Study ID Number: 120
ClinicalTrials.gov Identifier: NCT00002339
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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