A Study of Nystatin in the Prevention of Fungal Infections of the Mouth in Patients With AIDS or AIDS-Related Syndromes
NCT ID: NCT00002293
Last Updated: 2007-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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Nystatin
Eligibility Criteria
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Inclusion Criteria
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
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.
12 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Locations
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Birmingham Veterans Administration Med Ctr / Univ of Alabama
Birmingham, Alabama, United States
Bristol - Myers Squibb Co
Princeton, New Jersey, United States
Countries
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References
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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. doi: 10.1097/00042560-199608150-00005.
Other Identifiers
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5
Identifier Type: -
Identifier Source: secondary_id
026B
Identifier Type: -
Identifier Source: org_study_id