A Comparison of Fluconazole and Ketoconazole in the Treatment of Fungal Infections of the Throat in Patients With Weakened Immune Systems

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00002304
• Date of registration: 02/11/1999
• Prospective Registration: No
• Primary sponsor: Pfizer
• Public title: A Comparison of Fluconazole and Ketoconazole in the Treatment of Fungal Infections of the Throat in Patients With Weakened Immune Systems
• Scientific title: A Randomized Comparative Multicenter Trial of Fluconazole and Ketoconazole in the Treatment of Esophageal Candidiasis in Immunocompromised Patients
• Date of first enrolment: October 1997
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00002304
• Study type: Interventional
• Study design: Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Canada, United States

Key inclusion & exclusion 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.



Age minimum: 13 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

HIV Infections

Candidiasis, Esophageal

Intervention(s)

Drug: Fluconazole

Drug: Ketoconazole

Secondary ID(s)

012B

056-150

Source(s) of Monetary Support

Please refer to primary and secondary sponsors