A Study of Nystatin in the Prevention of Fungal Infections of the Mouth in Patients With AIDS or AIDS-Related Syndromes

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Completed

CT.gov ID

NCT00002293

Collaborator

(none)

Locations

Study Details

Study Description

Brief Summary

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

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

Nystatin Pastille for the Prophylaxis of Oral Candidiasis in Patients With AIDS or AIDS Related Syndromes

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:

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.

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