Candidiasis, Oral, HIV Infections
Conditions
Keywords
Nystatin, AIDS-Related Opportunistic Infections, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Candidiasis, Oral
Brief 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)
Interventions
DRUGNystatin
Sponsors
Bristol-Myers Squibb
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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.
Countries
United States
Outcome results
None listed