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 provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: April 1996
History of Changes
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.
Drug : Nystatin
Drug : Fluconazole
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:
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|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Oral hypoglycemics.
- Coumarin-type anticoagulants.
- 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.
- Patients with signs or symptoms of esophagitis (e.g., odynophagia) are not eligible unless esophagoscopy is performed and results are negative.
- 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).
- Antifungal agents other than study drugs.
- Other experimental medications.
- Other antifungal agents within the past 3 days.
Patients must have:
Patients with the following conditions are excluded:
Patients with the following prior conditions are excluded:
Known history of intolerance or allergy to imidazoles or triazoles or the polyene components of nystatin.
Contacts and LocationsChoosing 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 Show More
|United States, California|
|California Med Research Group|
|Fresno, California, United States, 93726|
|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 CollaboratorsPfizer
|ClinicalTrials.gov Identifier:||NCT00002112 History of Changes|
|Other Study ID Numbers:||012Q|
|Study First Received:||November 2, 1999|
|Last Updated:||June 23, 2005|
Keywords provided by NIH AIDS Clinical Trials Information Service:Nystatin
Acquired Immunodeficiency Syndrome
Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
ClinicalTrials.gov processed this data on February 28, 2020
This information is provided by ClinicalTrials.gov.