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...
Date First Received: November 2, 1999
Last Updated: October 1, 2007
Verified by: Bristol-Myers Squibb, October 2007
Clinical Trial Phase: N/A | Start Date:
Overall Status: Completed
Brief Summary
Official Title: “Nystatin Pastille for the Prophylaxis of Oral Candidiasis in Patients With AIDS or AIDS Related Syndromes”
Condition Keyword(s):
Intervention(s):
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)
Study Type: Interventional
Study Design: Treatment, Dose Comparison
Intervention(s) in this Clinical Trial
- Drug: Nystatin
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 12 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Bristol-Myers Squibb
Related Publications
References
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.
Additional Information
Information obtained from ClinicalTrials.gov on August 29, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00002293
Study ID Number: 026B
ClinicalTrials.gov Identifier: NCT00002293
Health Authority: United States: Food and Drug Administration
BMS Clinical Trials Disclosure
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