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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.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002112
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: April 1996
History of Changes
  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

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

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

No publications provided

ClinicalTrials.gov Identifier: NCT00002112     History of Changes
Other Study ID Numbers: 012Q, R-0223
Study First Received: November 2, 1999
Last Updated: June 23, 2005
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

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Candidiasis
Candidiasis, Oral
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases
Mycoses
 Mouth Diseases
Stomatognathic Diseases
Fluconazole
Nystatin
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Ionophores
Membrane Transport Modulators
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on June 18, 2013