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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Nystatin

Criteria

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.