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

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: HIV Infections; Candidiasis, Oral

Treatments: Drug: Nystatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002293

026B

5

Details and patient eligibility

About

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)

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.