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Nystatin Pastilles for the Prevention of Oral Candidiasis in Patients With AIDS or ARC
This study has been completed.
First Received: November 2, 1999   Last Updated: October 1, 2007   History of Changes
Sponsored by: Bristol-Myers Squibb
Information provided by: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00002057
  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: Treatment, Dose Comparison
Official Title: Nystatin Pastilles for the Prevention of Oral Candidiasis in Patients With AIDS or ARC

Resource links provided by NLM:

  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:
No publications provided

Study ID Numbers: 026A, 4
Study First Received: November 2, 1999
Last Updated: October 1, 2007
ClinicalTrials.gov Identifier: NCT00002057     History of Changes
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

Study placed in the following topic categories:
Mouth Diseases
Anti-Infective Agents
Opportunistic Infections
Candidiasis, Oral
Sexually Transmitted Diseases, Viral
Candidiasis
Acquired Immunodeficiency Syndrome
Nystatin
AIDS-Related Complex
Immunologic Deficiency Syndromes
Virus Diseases
Anti-Bacterial Agents
Mycoses
HIV Infections
Antifungal Agents
AIDS-Related Opportunistic Infections
Sexually Transmitted Diseases
Stomatognathic Diseases
Retroviridae Infections

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

ClinicalTrials.gov processed this record on September 02, 2009