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
Trial Information
Current as of July 01, 2025
Completed
Keywords
ClinConnect Summary
No description provided
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.
About Bristol Myers Squibb
Bristol-Myers Squibb (BMS) is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. With a robust portfolio of products across multiple therapeutic areas, including oncology, immunology, cardiovascular, and fibrotic diseases, BMS emphasizes cutting-edge research and a commitment to advancing medical science through clinical trials. The company is driven by a mission to provide transformative therapies, leveraging collaboration and scientific expertise to address unmet medical needs and improve patient outcomes worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Princeton, New Jersey, United States
Birmingham, Alabama, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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