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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
History of Changes
  Purpose

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).


Condition Intervention
Candidiasis, Oral
HIV Infections
 Drug: Nystatin

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Nystatin Pastilles for the Prevention of Oral Candidiasis in Patients With AIDS or ARC

Resource links provided by NLM:

Drug Information available for: Nystatin
U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002057

Locations
United States, Alabama
Birmingham Veterans Administration Med Ctr / Univ of Alabama
Birmingham, Alabama, United States, 35233
United States, New Jersey
Bristol - Myers Squibb Co
Princeton, New Jersey, United States, 085434000
Sponsors and Collaborators
Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00002057     History of Changes
Other Study ID Numbers: 026A, 4
Study First Received: November 2, 1999
Last Updated: October 1, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Nystatin
AIDS-Related Opportunistic Infections
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Candidiasis, Oral

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Candidiasis
Candidiasis, Oral
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
 Mycoses
Mouth Diseases
Stomatognathic Diseases
Nystatin
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Ionophores
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 23, 2013