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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00002057
First received: November 2, 1999
Last updated: October 1, 2007
Last verified: October 2007

November 2, 1999
October 1, 2007
Not Provided
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00002057 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Nystatin Pastilles for the Prevention of Oral Candidiasis in Patients With AIDS or ARC
Nystatin Pastilles for the Prevention of Oral Candidiasis in Patients With AIDS or ARC

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).

Not Provided
Interventional
Not Provided
Primary Purpose: Treatment
  • Candidiasis, Oral
  • HIV Infections
Drug: Nystatin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
Not Provided
Not Provided

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.
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002057
026A, 4
Not Provided
Not Provided
Bristol-Myers Squibb
Not Provided
Not Provided
Bristol-Myers Squibb
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP