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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002293
• Other study ID #: 026B
• Secondary ID: 5
• 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 prophylaxis of oral candidiasis in patients with AIDS or AIDS related syndromes (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:

• 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.

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Oral
• HIV Infections
• Infection

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, 

References & Publications (1)

MacPhail LA, Hilton JF, Dodd CL, Greenspan D. Prophylaxis with nystatin pastilles for HIV-associated oral candidiasis. J Acquir Immune Defic Syndr Hum Retrovirol. 1996 Aug 15;12(5):470-6. — View Citation

External Links

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