Nystatin Pastilles for the Prevention of Oral Candidiasis in Patients With AIDS or ARC

HIV Infections Clinical Trial

Official title:

Nystatin Pastilles for the Prevention of Oral Candidiasis in Patients With AIDS or ARC

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002057
• Other study ID #: 026A
• Secondary ID: 4
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: October 1, 2007

Study information

• Verified date: October 2007
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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.

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Oral
• HIV Infections

Intervention

Drug:
• Nystatin

Locations

Country	Name	City	State
United States	Birmingham Veterans Administration Med Ctr / Univ of Alabama	Birmingham	Alabama
United States	Bristol - Myers Squibb Co	Princeton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm