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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on November 20, 2014