Nystatin Troche |
Mycostatin Pastilles |
Clinical Trial: A Study of Nystatin in the Prevention of Fungal Infections of the Mouth in Patients with AIDS or AIDS-Related Syndromes
This study is no longer recruiting patients.
|
Purpose
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 | Treatment or Intervention |
|---|---|
| Candidiasis, Oral HIV Infections | Drug: Nystatin |
MedlinePlus related topics: AIDS; Candidiasis
Study Type: Interventional
Study Design: Treatment, Dose Comparison
Official Title: Nystatin Pastille for the Prophylaxis of Oral Candidiasis in Patients with AIDS or AIDS Related Syndromes
Eligibility
Ages Eligible for Study: 12 Years and above, Genders Eligible for Study: Both
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.
Location Information
Alabama
Birmingham Veterans Administration Med Ctr / Univ of Alabama, Birmingham, Alabama, 35233, United States
New Jersey
Bristol - Myers Squibb Co, Princeton, New Jersey, 085434000, United States
More Information
Publications
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.
Record last reviewed: August 2004
Last Updated: October 13, 2004
Record first received: November 2, 1999
ClinicalTrials.gov Identifier: NCT00002293
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Mycostatin Pastilles (Drug Digest)
- Nystatin Troche (Drug Digest)

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