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

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: 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.

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
NCT00002057
Brief Title
Nystatin Pastilles for the Prevention of Oral Candidiasis in Patients With AIDS or ARC
Official Title
Nystatin Pastilles for the Prevention of Oral Candidiasis in Patients With AIDS or ARC
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 prevention of oral candidiasis in patients with AIDS or AIDS related complex (ARC) (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: 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.
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

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

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