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

Last updated on February 22, 2019

FOR MORE INFORMATION
Study Location
Good Samaritan Med Ctr
Phoenix, Arizona, 85006 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Esophageal Candidiasis, HIV Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
13-70 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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Prior Medication:

Allowed:

- Cyclosporin if levels can be monitored for proper cyclosporin dose adjustment.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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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

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.

NCT00002304
Pfizer
Completed
A Comparison of Fluconazole and Ketoconazole in the Treatment of Fungal Infections of the Throat in Patients With Weakened Immune Systems

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Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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