A Comparison of Fluconazole and Ketoconazole in the Treatment of Fungal Infections of the Throat in Patients With Weakened Immune Systems
This study has been completed.
Sponsor:
Pfizer
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002304
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: February 1990
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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: | Primary Purpose: Treatment |
| Official Title: | A Randomized Comparative Multicenter Trial of Fluconazole and Ketoconazole in the Treatment of Esophageal Candidiasis in Immunocompromised Patients |
Resource links provided by NLM:
Further study details as provided by NIH AIDS Clinical Trials Information Service:
Eligibility| Ages Eligible for Study: | 13 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria
Prior Medication:
Allowed:
- Cyclosporin if levels can be monitored for proper cyclosporin dose adjustment.
Exclusion Criteria
Co-existing Condition:
Patients with the following are excluded:
- Evidence of noncandidal systemic fungal infections.
- Leukopenia (white blood cell count less than 1000/mm3), or expected to develop leukopenia during the study.
- Other condition known to be associated with poor ketoconazole absorption, e.g., hypochlorhydria.
- Leukemia requiring chemotherapy.
- Any other condition which in the opinion of the investigator would make the patient unsuitable for enrollment.
Concurrent Medication:
Excluded:
- Warfarin.
- Immunostimulants.
- Interferon.
- Oral or topical antifungal agents.
Concurrent Treatment:
Excluded:
- Lymphocyte replacement.
Patients with the following are excluded:
- History of allergy to imidazoles.
- Abnormalities which may preclude esophagoscopy or endoscopy before or during the study.
- Inability to tolerate fluconazole or ketoconazole.
- Inability or unwillingness to give written informed consent.
- Life expectancy < 2 months.
Prior Medication:
Excluded:
- Rifampin or ansamycin, pending clarification of drug interactions between these drugs and fluconazole.
- Warfarin.
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002304
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Show 42 Study LocationsSponsors and Collaborators
Pfizer
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00002304 History of Changes |
| Other Study ID Numbers: | 012B, 056-150 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by NIH AIDS Clinical Trials Information Service:
|
AIDS-Related Opportunistic Infections Immune Tolerance Ketoconazole Esophagitis |
Fluconazole Acquired Immunodeficiency Syndrome Candidiasis, Oral |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Candidiasis Esophageal Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
Mycoses Gastrointestinal Diseases Digestive System Diseases Fluconazole Ketoconazole Antifungal Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions 14-alpha Demethylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013