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| Descriptive Information Fields | |
| Brief Title † | A Study of Fluconazole in the Treatment of Fungal Infections of the Throat in Patients With Weakened Immune Systems |
| Official Title † | An Open Multicenter Trial of Fluconazole Oral Suspension in the Treatment of Esophageal Candidiasis in Immunocompromised Patients |
| Brief Summary | To determine the safety, toleration, and efficacy of fluconazole oral suspension in the treatment of esophageal candidiasis in immunocompromised patients, including those with AIDS. |
| Detailed 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. |
| Study Phase | Phase III |
| Study Type † | Interventional |
| Study Design † | Treatment, Safety Study |
| Primary Outcome Measure † | |
| Secondary Outcome Measure † | |
| Condition † | Candidiasis, Esophageal HIV Infections |
| Intervention † | Drug: Fluconazole |
| MEDLINE PMIDs | 7957784 |
| Links | |
| Recruitment Information Fields | |
| Recruitment Status † | Completed |
| Enrollment † | 100 |
| Start Date † | |
| Completion Date | |
| Eligibility Criteria † | 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:
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| Gender | Both |
| Ages | 13 Years to 70 Years |
| Accepts Healthy Volunteers | No |
| Contacts †† | |
| Location Countries † | United States |
| Administrative Information Fields | |
| NCT ID † | NCT00002339 |
| Organization ID | 120 |
| Secondary IDs †† | R-0220 |
| Study Sponsor † | Pfizer |
| Collaborators †† | |
| Investigators † | |
| Information Provided By | NIH AIDS Clinical Trials Information Service |
| Verification Date | April 1996 |
| First Received Date † | November 2, 1999 |
| Last Updated Date | June 23, 2005 |