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

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Completed

CT.gov ID

NCT00002057

Collaborator

(none)

Locations

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Candidiasis, Oral HIV Infections	Drug: Nystatin	N/A

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Birmingham Veterans Administration Med Ctr / Univ of Alabama	Birmingham	Alabama	United States	35233
2	Bristol - Myers Squibb Co	Princeton	New Jersey	United States	085434000