A Study of Nystatin in the Prevention of Fungal Infections of the Mouth in Patients With AIDS or AIDS-Related Syndromes

• 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 prophylaxis of oral candidiasis in patients with AIDS or AIDS related syndromes (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:

• Experimental drugs (IND drugs) which are targeted specifically against the AIDS virus or which stimulate the immune system.

• Systemic or oral antibiotics.

Patients must have AIDS or AIDS-related syndromes (HIV infection:

• Group III or IV, CDC classification) and not have been treated for oral candidiasis during the past year.

• Patients can be entered into the study who have:

• Other oral lesions due to Kaposi's sarcoma, herpes zoster, and herpes simplex.

• A positive or negative oral culture for Candida.

• Must be able to follow instructions regarding the use of a pastille.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

• Oral lesions diagnostic of oral candidiasis or systemic candidiasis.

• Suspected or proven candidal esophagitis.

Patients with the following are excluded:

• Oral lesions diagnostic of oral candidiasis or systemic candidiasis.

• Receiving any effective antifungal agent orally or intravenously within 72 hours of study entry.

• Not expected to survive for at least 6 months.

• Unable to voluntarily maintain a pastille in the buccal cavity for approximately 20 minutes twice a day.

• Known hypersensitivity to nystatin.

• Suspected or proven candidal esophagitis.

Prior Medication:

Excluded within 72 hours of study entry:

• Any oral or intravenous antifungal agent.