- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002057
Nystatin Pastilles for the Prevention of Oral Candidiasis in Patients With AIDS or ARC
October 1, 2007 updated by: Bristol-Myers Squibb
To determine a safe, effective, and convenient dosing schedule for nystatin pastilles in the prevention of oral candidiasis in patients with AIDS or AIDS related complex (ARC) (group III or IV, CDC classification).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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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Alabama
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Birmingham, Alabama, United States, 35233
- Birmingham Veterans Administration Med Ctr / Univ of Alabama
-
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New Jersey
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Princeton, New Jersey, United States, 085434000
- Bristol - Myers Squibb Co
-
-
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
10 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria
Concurrent Medication:
Allowed:
- Systemic or oral antibiotics.
- Experimental drugs (IND drugs) which are targeted specifically against the AIDS (group IV CDC classification) virus or stimulate the immune system.
Patients with the following conditions are included:
- AIDS or AIDS related complex (ARC) (HIV infection Group 3 or 4, CDC classification) who have had culture-proven oral candidiasis clinically cured within 7 days of study entry and are likely to be compliant for the 20 weeks of nystatin pastille prophylaxis.
- Able to follow instructions regarding the use of a pastille.
- Patients entering part II of this study (randomized double-blind) must have been clinically cured of oral candidiasis within 1 - 7 days of entry into this randomized study.
- Oral lesions such as Kaposi's sarcoma, herpes zoster, and herpes simplex can be enrolled.
Exclusion Criteria
Co-existing Condition:
Patients with the following are excluded:
- Systemic candidiasis.
- Hypersensitivity to nystatin.
- Suspected or proven candidal esophagitis.
Patients with the following are excluded:
- Systemic candidiasis.
- Projected survival of less than 6 months.
- Unable to maintain a pastille in the buccal cavity for approximately 20 minutes twice a day.
- Hypersensitivity to nystatin.
- Suspected or proven candidal esophagitis.
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
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)
October 2, 2007
Last Update Submitted That Met QC Criteria
October 1, 2007
Last Verified
October 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 026A
- 4
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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