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

Completed · Not applicable

Conditions studied: Candidiasis, Oral, HIV Infections

In brief

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)

Key facts

Study ID

NCT00002293

Run by

Bristol-Myers Squibb

Last updated by the study team

2007-10-02

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Birmingham Veterans Administration Med Ctr / Univ of Alabama — Birmingham, Alabama, United States
• Bristol - Myers Squibb Co — Princeton, New Jersey, United States

Full record on ClinicalTrials.gov

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