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

NCT00002293 | Completed

• 2 other identifiers: 026B5
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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)

Conditions

Candidiasis, Oral; HIV Infections

Keywords

Nystatin; AIDS-Related Opportunistic Infections; Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Candidiasis, Oral

Interventions

Nystatin DRUG

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (2)

Birmingham Veterans Administration Med Ctr / Univ of Alabama

Birmingham, Alabama, 35233, United States

Location

Bristol - Myers Squibb Co

Princeton, New Jersey, 085434000, United States

Location

Related 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. doi: 10.1097/00042560-199608150-00005.

  PMID: 8757423 BACKGROUND

MeSH Terms

Conditions

Candidiasis, Oral; HIV Infections; AIDS-Related Opportunistic Infections; Acquired Immunodeficiency Syndrome; AIDS-Related Complex

Interventions

Nystatin

Condition Hierarchy (Ancestors)

Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Mouth Diseases; Stomatognathic Diseases; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Opportunistic Infections; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Last Updated: October 2, 2007

Record last verified: 2007-10

Locations

US (2)