- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002112
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
June 23, 2005 updated by: Pfizer
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.
Study Overview
Status
Completed
Conditions
Intervention / 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.
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Fresno, California, United States, 93726
- California Med Research Group
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San Francisco, California, United States, 94143
- UCSF Hosp
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Maryland
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Baltimore, Maryland, United States, 21205
- Johns Hopkins School of Medicine
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19129
- Med College of Pennsylvania
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Virginia
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Hampton, Virginia, United States, 23666
- Hampton Roads Med Specialists
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Interventional Model: Parallel Assignment
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
November 2, 1999
First Submitted That Met QC Criteria
August 30, 2001
First Posted (Estimate)
August 31, 2001
Study Record Updates
Last Update Posted (Estimate)
June 24, 2005
Last Update Submitted That Met QC Criteria
June 23, 2005
Last Verified
April 1, 1996
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immune System Diseases
- Stomatognathic Diseases
- Mouth Diseases
- Bacterial Infections and Mycoses
- Mycoses
- Slow Virus Diseases
- HIV Infections
- Candidiasis
- Acquired Immunodeficiency Syndrome
- Immunologic Deficiency Syndromes
- Candidiasis, Oral
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Anti-Bacterial Agents
- Membrane Transport Modulators
- Cytochrome P-450 Enzyme Inhibitors
- Hormone Antagonists
- Antifungal Agents
- Steroid Synthesis Inhibitors
- 14-alpha Demethylase Inhibitors
- Cytochrome P-450 CYP2C9 Inhibitors
- Cytochrome P-450 CYP2C19 Inhibitors
- Ionophores
- Fluconazole
- Nystatin
Other Study ID Numbers
- 012Q
- R-0223
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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