Nystatin Troche |
Mycostatin Pastilles |
Clinical Trial: Nystatin Pastilles for the Prevention of Oral Candidiasis in Patients With AIDS or ARC
This study is no longer recruiting patients.
|
Purpose
To determine a safe, effective, and convenient dosing schedule for nystatin pastilles in the prevention of oral candidiasis in patients with AIDS or AIDS related complex (ARC) (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
Eligibility
Ages Eligible for Study: 12 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria
Concurrent Medication: Allowed:
- Systemic or oral antibiotics.
- Experimental drugs (IND drugs) which are targeted specifically against the AIDS (group IV CDC classification) virus or stimulate the immune system.
Patients with the following conditions are included:
- AIDS or AIDS related complex (ARC) (HIV infection Group 3 or 4, CDC classification) who have had culture-proven oral candidiasis clinically cured within 7 days of study entry and are likely to be compliant for the 20 weeks of nystatin pastille prophylaxis.
- Able to follow instructions regarding the use of a pastille.
- Patients entering part II of this study (randomized double-blind) must have been clinically cured of oral candidiasis within 1 - 7 days of entry into this randomized study.
- Oral lesions such as Kaposi's sarcoma, herpes zoster, and herpes simplex can be enrolled.
Exclusion Criteria
Co-existing Condition: Patients with the following are excluded:
- Systemic candidiasis.
- Hypersensitivity to nystatin.
- Suspected or proven candidal esophagitis.
Patients with the following are excluded:
- Systemic candidiasis.
- Projected survival of less than 6 months.
- Unable to maintain a pastille in the buccal cavity for approximately 20 minutes twice a day.
- Hypersensitivity to nystatin.
- Suspected or proven candidal esophagitis.
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
Record last reviewed: August 2004
Last Updated: October 13, 2004
Record first received: November 2, 1999
ClinicalTrials.gov Identifier: NCT00002057
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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