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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.

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

MedlinePlus related topics:   AIDS    Yeast Infections   

Drug Information available for:   Nystatin   

U.S. FDA Resources

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
  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


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
 

Publications:

Study ID Numbers:   026B, 5
First Received:   November 2, 1999
Last Updated:   October 1, 2007
ClinicalTrials.gov Identifier:   NCT00002293
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
Opportunistic Infections
Candidiasis, Oral
Sexually Transmitted Diseases, Viral
Candidiasis
Clotrimazole
Miconazole
Acquired Immunodeficiency Syndrome
Tioconazole
Nystatin
AIDS-Related Complex
Immunologic Deficiency Syndromes
Virus Diseases
Mycoses
HIV Infections
AIDS-Related Opportunistic Infections
Sexually Transmitted Diseases
Stomatognathic Diseases
Retroviridae Infections

Additional relevant MeSH terms:
Communicable Diseases
Anti-Infective Agents
RNA Virus Infections
Slow Virus Diseases
Disease
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Infection
Pharmacologic Actions
Membrane Transport Modulators
Anti-Bacterial Agents
Pathologic Processes
Syndrome
Antifungal Agents
Therapeutic Uses
Lentivirus Infections
Ionophores

ClinicalTrials.gov processed this record on November 20, 2008




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