A Study of Nystatin in the Prevention of Fungal Infections of the Mouth in Patients With AIDS or AIDS-Related Syndromes
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00002293
First received: November 2, 1999
Last updated: October 1, 2007
Last verified: October 2007
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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)
Condition | Intervention |
---|---|
Candidiasis, Oral HIV Infections |
Drug: Nystatin |
Study Type: | Interventional |
Study Design: | Primary Purpose: Treatment |
Official Title: | Nystatin Pastille for the Prophylaxis of Oral Candidiasis in Patients With AIDS or AIDS Related Syndromes |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
Drug Information available for:
Nystatin
U.S. FDA Resources
Further study details as provided by Bristol-Myers Squibb:
![](https://webarchive.library.unt.edu/web/20130312000611im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00002293
Locations
United States, Alabama | |
Birmingham Veterans Administration Med Ctr / Univ of Alabama | |
Birmingham, Alabama, United States, 35233 | |
United States, New Jersey | |
Bristol - Myers Squibb Co | |
Princeton, New Jersey, United States, 085434000 |
Sponsors and Collaborators
Bristol-Myers Squibb
![](https://webarchive.library.unt.edu/web/20130312000611im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Additional Information:
Publications:
ClinicalTrials.gov Identifier: | NCT00002293 History of Changes |
Other Study ID Numbers: | 026B, 5 |
Study First Received: | November 2, 1999 |
Last Updated: | October 1, 2007 |
Health Authority: | United States: Food and Drug Administration |
Keywords provided by Bristol-Myers Squibb:
Nystatin AIDS-Related Opportunistic Infections Acquired Immunodeficiency Syndrome AIDS-Related Complex Candidiasis, Oral |
Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome HIV Infections Candidiasis Candidiasis, Oral Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Mycoses Mouth Diseases Stomatognathic Diseases Nystatin Antifungal Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Ionophores Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on March 10, 2013