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Sponsored by: |
Pfizer |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002304 |
To compare the safety, tolerance, and effectiveness of fluconazole and ketoconazole in the treatment of candidal esophagitis in immunocompromised patients.
Condition | Intervention |
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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 |
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.
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 Opportunistic Infections Sexually Transmitted Diseases, Viral Candidiasis, Oral Candidiasis Gastrointestinal Diseases Acquired Immunodeficiency Syndrome Ketoconazole Immunologic Deficiency Syndromes Virus Diseases |
Mycoses Esophagitis Digestive System Diseases Esophageal Disorder HIV Infections Antifungal Agents AIDS-Related Opportunistic Infections Sexually Transmitted Diseases Esophageal Diseases Retroviridae Infections |
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 |