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Comparative Randomized Study of the Efficacy, Safety, and Toleration of Fluconazole Oral Suspension or Nystatin Oral Suspension in the Treatment of Patients With Oropharyngeal Candidiasis in Association With the Acquired Immunodeficiency Syndrome

Last updated on March 14, 2019

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Study Location
California Med Research Group
Fresno, California, 93726 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Oral Candidiasis, HIV Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
13 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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Concurrent Medication:

Allowed:

- Phenytoin.

- Oral hypoglycemics.

- Coumarin-type anticoagulants.

- Cyclosporine.

Patients must have:

- ARC or AIDS.

- Signs of oropharyngeal candidiasis (i.e., typical white plaques) with some associated
symptoms.

- Confirmation of diagnosis by microscopic exam and culture of organism.

- Life expectancy of at least 4 weeks.

NOTE:

- Patients with signs or symptoms of esophagitis (e.g., odynophagia) are not eligible
unless esophagoscopy is performed and results are negative.

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 conditions are excluded:

- Unable to tolerate oral medication.

- Concurrent enrollment on another experimental trial of approved or non-approved drugs
or systemic compounds (without approval of Pfizer clinical monitor).

Concurrent Medication:

Excluded:

- Antifungal agents other than study drugs.

- Other experimental medications.

Patients with the following prior conditions are excluded:

Known history of intolerance or allergy to imidazoles or triazoles or the polyene
components of nystatin.

Prior Medication:

Excluded:

- Other antifungal agents within the past 3 days.

NCT00002112
Pfizer
Completed
Comparative Randomized Study of the Efficacy, Safety, and Toleration of Fluconazole Oral Suspension or Nystatin Oral Suspension in the Treatment of Patients With Oropharyngeal Candidiasis in Association With the Acquired Immunodeficiency Syndrome

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