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

Primary Purpose

Candidiasis, Oral, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nystatin
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Candidiasis, Oral focused on measuring Nystatin, AIDS-Related Opportunistic Infections, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Candidiasis, Oral

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Birmingham Veterans Administration Med Ctr / Univ of Alabama
  • Bristol - Myers Squibb Co

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 1, 2007
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00002293
Brief Title
A Study of Nystatin in the Prevention of Fungal Infections of the Mouth in Patients With AIDS or AIDS-Related Syndromes
Official Title
Nystatin Pastille for the Prophylaxis of Oral Candidiasis in Patients With AIDS or AIDS Related Syndromes
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

5. 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Candidiasis, Oral, HIV Infections
Keywords
Nystatin, AIDS-Related Opportunistic Infections, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Candidiasis, Oral

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Nystatin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Birmingham Veterans Administration Med Ctr / Univ of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Bristol - Myers Squibb Co
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
085434000
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
8757423
Citation
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.
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A Study of Nystatin in the Prevention of Fungal Infections of the Mouth in Patients With AIDS or AIDS-Related Syndromes

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