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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00002293 |
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Date of registration:
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02/11/1999 |
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Primary sponsor: |
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Public title:
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A Study of Nystatin in the Prevention of Fungal Infections of the Mouth in Patients With AIDS or AIDS-Related Syndromes
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Scientific title:
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Nystatin Pastille for the Prophylaxis of Oral Candidiasis in Patients With AIDS or AIDS Related Syndromes |
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Date of first enrolment:
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October 1997 |
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Target sample size:
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00002293 |
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Study type:
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Interventional |
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Study design:
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Primary Purpose: Treatment
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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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.
Age minimum:
12 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Candidiasis, Oral
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HIV Infections
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Intervention(s)
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Drug: Nystatin
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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