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A Study of Nystatin in the Prevention of Fungal Infections of the Mouth in Patients With AIDS or AIDS-Related Syndromes
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: NCT00002293
  Purpose

To determine a safe, effective, and convenient dosing schedule for nystatin pastilles in the prophylaxis of oral candidiasis in patients with AIDS or AIDS related syndromes (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 Pastille for the Prophylaxis of Oral Candidiasis in Patients With AIDS or AIDS Related Syndromes

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:

  • Experimental drugs (IND drugs) which are targeted specifically against the AIDS virus or which stimulate the immune system.
  • Systemic or oral antibiotics.

Patients must have AIDS or AIDS-related syndromes (HIV infection:

  • Group III or IV, CDC classification) and not have been treated for oral candidiasis during the past year.
  • Patients can be entered into the study who have:
  • Other oral lesions due to Kaposi's sarcoma, herpes zoster, and herpes simplex.
  • A positive or negative oral culture for Candida.
  • Must be able to follow instructions regarding the use of a pastille.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

  • Oral lesions diagnostic of oral candidiasis or systemic candidiasis.
  • Suspected or proven candidal esophagitis.

Patients with the following are excluded:

  • Oral lesions diagnostic of oral candidiasis or systemic candidiasis.
  • Receiving any effective antifungal agent orally or intravenously within 72 hours of study entry.
  • Not expected to survive for at least 6 months.
  • Unable to voluntarily maintain a pastille in the buccal cavity for approximately 20 minutes twice a day.
  • Known hypersensitivity to nystatin.
  • Suspected or proven candidal esophagitis.

Prior Medication:

Excluded within 72 hours of study entry:

  • Any oral or intravenous antifungal agent.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002293

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:
Publications:
Study ID Numbers: 026B, 5
Study First Received: November 2, 1999
Last Updated: October 1, 2007
ClinicalTrials.gov Identifier: NCT00002293     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
Communicable Diseases
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Candidiasis, Oral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Candidiasis
Nystatin
Infection
Membrane Transport Modulators
Anti-Bacterial Agents
Mycoses
Pathologic Processes
Syndrome
Antifungal Agents
Therapeutic Uses
Ionophores
Retroviridae Infections
RNA Virus Infections
Disease
Immune System Diseases
Acquired Immunodeficiency Syndrome
Pharmacologic Actions
Immunologic Deficiency Syndromes
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Stomatognathic Diseases

ClinicalTrials.gov processed this record on September 02, 2009