Nystatin Pastilles for the Prevention of Oral Candidiasis in Patients With AIDS or ARC
Information source: Bristol-Myers Squibb
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Candidiasis, Oral; HIV Infections
Intervention: Nystatin (Drug)
Phase: N/A
Status: Completed
Sponsored by: Bristol-Myers Squibb
Summary
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).
Clinical Details
Official title: Nystatin Pastilles for the Prevention of Oral Candidiasis in Patients With AIDS or ARC
Study design: Treatment, Dose Comparison
Eligibility
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): 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.
Locations and Contacts
Birmingham Veterans Administration Med Ctr / Univ of Alabama, Birmingham, Alabama 35233, United States
Bristol - Myers Squibb Co, Princeton, New Jersey 085434000, United States
Additional Information
BMS Clinical Trials Disclosure For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm
Last updated: October 1, 2007
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