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| Sponsored by: |
Pfizer |
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002339 |
Purpose
To determine the safety, toleration, and efficacy of fluconazole oral suspension in the treatment of esophageal candidiasis in immunocompromised patients, including those with AIDS.
| Condition | Intervention | Phase |
|
Candidiasis, Esophageal HIV Infections |
Drug: Fluconazole |
Phase III |
| MedlinePlus related topics: | AIDS Esophagus Disorders Yeast Infections |
| ChemIDplus related topics: | Fluconazole |
| Study Type: | Interventional |
| Study Design: | Treatment, Safety Study |
| Official Title: | An Open Multicenter Trial of Fluconazole Oral Suspension in the Treatment of Esophageal Candidiasis in Immunocompromised Patients |
| Estimated Enrollment: | 100 |
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.
Eligibility
| Ages Eligible for Study: | 13 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following prior condition are excluded:
History of allergy to imidazoles or azoles.
Prior Medication:
Excluded:
Contacts and Locations| United States, California | |||||
| Los Angeles County - USC Med Ctr | |||||
| Los Angeles, California, United States, 90033 | |||||
| United States, Texas | |||||
| Houston Veterans Administration Med Ctr | |||||
| Houston, Texas, United States, 77030 | |||||
| Pfizer |
More Information
| Study ID Numbers: | 120, R-0220 |
| First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002339 |
| Health Authority: | United States: Food and Drug Administration |
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