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

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: HIV Infections; Candidiasis, Oral

Treatments: Drug: Nystatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002057

4

026A

Details and patient eligibility

About

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).

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.