Official Title: “Nystatin Pastilles for the Prevention of Oral Candidiasis in Patients With AIDS or ARC”

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 Type: Interventional

Study Design: Treatment, Dose Comparison

Intervention(s) in this Clinical Trial

• Drug: Nystatin

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Bristol-Myers Squibb

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00002057

Study ID Number: 026A

ClinicalTrials.gov Identifier: NCT00002057

Health Authority: United States: Food and Drug Administration

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