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

Launched by BRISTOL-MYERS SQUIBB · Aug 30, 2001

Keywords

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Gender

ALL

Eligibility 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.