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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

Information source: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Candidiasis, Oral; HIV Infections

Intervention: Nystatin (Drug); Fluconazole (Drug)

Phase: N/A

Status: Completed

Sponsored by: Pfizer

Summary

To compare the efficacy, safety, and toleration of fluconazole as a single daily oral suspension for 14 days versus nystatin oral suspension 4 times daily for 14 days in the treatment of oropharyngeal candidiasis in patients with AIDS or HIV infection.

Clinical Details

Official title: 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

Study design: Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Detailed description: Patients are randomized to receive fluconazole oral suspension once daily (swallowed at approximately the same time every day) for 14 days or nystatin oral suspension used to rinse the mouth four times daily for 14 days. No food or drink is permitted immediately following the administration of the nystatin.

Eligibility

Minimum age: 13 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria 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 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.

Locations and Contacts

California Med Research Group, Fresno, California 93726, United States

UCSF Hosp, San Francisco, California 94143, United States

Johns Hopkins School of Medicine, Baltimore, Maryland 21205, United States

Med College of Pennsylvania, Philadelphia, Pennsylvania 19129, United States

Hampton Roads Med Specialists, Hampton, Virginia 23666, United States

Additional Information


Last updated: June 23, 2005

Page last updated: August 23, 2015

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