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| Sponsor: | Pfizer |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002304 |
Purpose
To compare the safety, tolerance, and effectiveness of fluconazole and ketoconazole in the treatment of candidal esophagitis in immunocompromised patients.
| Condition | Intervention |
|---|---|
|
Candidiasis, Esophageal HIV Infections |
Drug: Ketoconazole Drug: Fluconazole |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Randomized Comparative Multicenter Trial of Fluconazole and Ketoconazole in the Treatment of Esophageal Candidiasis in Immunocompromised Patients |
Eligibility| Ages Eligible for Study: | 13 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following are excluded:
Concurrent Medication:
Excluded:
Concurrent Treatment:
Excluded:
Patients with the following are excluded:
Prior Medication:
Excluded:
Patients must meet the CDC criteria for the diagnosis of AIDS or be otherwise immunocompromised (e.g., malignancy, renal transplant) and have a diagnosis of oral candidiasis and/or esophageal symptoms of dysphagia and/or odynophagia.
Illicit or illegal drug use.
Contacts and Locations
Show 42 Study Locations
More Information
| Study ID Numbers: | 012B, 056-150 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002304 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
AIDS-Related Opportunistic Infections Immune Tolerance Ketoconazole Esophagitis |
Fluconazole Acquired Immunodeficiency Syndrome Candidiasis, Oral |
|
Fluconazole Anti-Infective Agents Communicable Diseases RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Immune System Diseases Candidiasis Gastrointestinal Diseases Acquired Immunodeficiency Syndrome Ketoconazole Infection |
Pharmacologic Actions Immunologic Deficiency Syndromes Virus Diseases Mycoses Digestive System Diseases HIV Infections Therapeutic Uses Antifungal Agents Sexually Transmitted Diseases Lentivirus Infections Esophageal Diseases Retroviridae Infections |