A Study of Nystatin in the Prevention of Fungal Infections of the Mouth in Patients With AIDS or AIDS-Related Syndromes
Information source: Bristol-Myers Squibb
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Candidiasis, Oral; HIV Infections
Intervention: Nystatin (Drug)
Phase: N/A
Status: Completed
Sponsored by: Bristol-Myers Squibb
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)
Clinical Details
Official title: Nystatin Pastille for the Prophylaxis of Oral Candidiasis in Patients With AIDS or AIDS Related Syndromes
Study design: Treatment, Dose Comparison
Eligibility
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Birmingham Veterans Administration Med Ctr / Univ of Alabama, Birmingham, Alabama 35233, United States
Bristol - Myers Squibb Co, Princeton, New Jersey 085434000, United States
Additional Information
BMS Clinical Trials Disclosure For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm
Related publications: MacPhail LA, Hilton JF, Dodd CL, Greenspan D. Prophylaxis with nystatin pastilles for HIV-associated oral candidiasis. J Acquir Immune Defic Syndr Hum Retrovirol. 1996 Aug 15;12(5):470-6.
Last updated: October 1, 2007
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