Clinical Trials

MainTitle

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
Pfizer


Information provided by (Responsible Party)
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

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: 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

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

Eligibility

Ages Eligible for Study: 13 Years and older  
Sexes Eligible for Study: All  
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

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

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

More Information


Responsible Party: Pfizer  
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  

Keywords provided by NIH AIDS Clinical Trials Information Service:

Nystatin
Fluconazole
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Candidiasis, Oral

Additional relevant MeSH terms:
HIV Infections
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
Candidiasis
Candidiasis, Oral
Fluconazole
Nystatin

ClinicalTrials.gov processed this data on December 14, 2017
This information is provided by ClinicalTrials.gov.