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Nystatin Pastilles for the Prevention of Oral Candidiasis in Patients With AIDS or ARC | Clinical Trials | Clareo Health

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Nystatin Pastilles for the Prevention of Oral Candidiasis in Patients With AIDS or ARC

NCT00002057•Bristol-Myers Squibb

View on ClinicalTrials.gov

Summary

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).

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

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.
+1 more criteria

Locations (2)

Birmingham Veterans Administration Med Ctr / Univ of Alabama

Birmingham, Alabama, United States

Bristol - Myers Squibb Co

Princeton, New Jersey, United States

Key Dates

Last Updated

October 2, 2007

Conditions

Candidiasis, OralHIV Infections

Interventions

Nystatin

DRUG

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HIVHIV Infections

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RECRUITINGPHASE3

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 2, 2007Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Nystatin Pastilles for the Prevention of Oral Candidiasis in Patients With AIDS or ARC

Inclusion Criteria

Exclusion Criteria

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