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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

This study has been completed.

Sponsored by: Pfizer
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002112
  Purpose

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.


Condition Intervention
Candidiasis, Oral
HIV Infections
Drug: Nystatin
Drug: Fluconazole

MedlinePlus related topics:   AIDS    Yeast Infections   

ChemIDplus related topics:   Fluconazole    Nystatin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Parallel Assignment, Safety Study
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

Further study details as provided by NIH AIDS Clinical Trials Information Service:

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
Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002112

Locations
United States, California
California Med Research Group    
      Fresno, California, United States, 93726
UCSF Hosp    
      San Francisco, California, United States, 94143
United States, Maryland
Johns Hopkins School of Medicine    
      Baltimore, Maryland, United States, 21205
United States, Pennsylvania
Med College of Pennsylvania    
      Philadelphia, Pennsylvania, United States, 19129
United States, Virginia
Hampton Roads Med Specialists    
      Hampton, Virginia, United States, 23666

Sponsors and Collaborators
Pfizer
  More Information


Study ID Numbers:   012Q, R-0223
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002112
Health Authority:   United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Nystatin  
Fluconazole  
Acquired Immunodeficiency Syndrome  
AIDS-Related Complex  
Candidiasis, Oral  

Study placed in the following topic categories:
Fluconazole
Mouth Diseases
Candidiasis, Oral
Sexually Transmitted Diseases, Viral
Candidiasis
Clotrimazole
Miconazole
Acquired Immunodeficiency Syndrome
Tioconazole
Nystatin
AIDS-Related Complex
Immunologic Deficiency Syndromes
Virus Diseases
Mycoses
HIV Infections
Sexually Transmitted Diseases
Stomatognathic Diseases
Retroviridae Infections

Additional relevant MeSH terms:
Anti-Infective Agents
RNA Virus Infections
Slow Virus Diseases
Disease
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Infection
Pharmacologic Actions
Membrane Transport Modulators
Anti-Bacterial Agents
Pathologic Processes
Syndrome
Antifungal Agents
Therapeutic Uses
Lentivirus Infections
Ionophores

ClinicalTrials.gov processed this record on October 10, 2008




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