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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 - Article


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Nystatin Troche

Mycostatin Pastilles 




Clinical Trial: A Study of Nystatin in the Prevention of Fungal Infections of the Mouth in Patients with AIDS or AIDS-Related Syndromes

This study is no longer recruiting patients.

Sponsored by: Bristol-Myers Squibb
Information provided by: Bristol-Myers Squibb

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 Treatment or Intervention
Candidiasis, Oral
HIV Infections
 Drug: Nystatin

MedlinePlus related topics:  AIDS;   Candidiasis

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 above,  Genders Eligible for Study:  Both

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:

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:


Location Information


Alabama
      Birmingham Veterans Administration Med Ctr / Univ of Alabama, Birmingham,  Alabama,  35233,  United States

New Jersey
      Bristol - Myers Squibb Co, Princeton,  New Jersey,  085434000,  United States

More Information

Publications

MacPhail LA, Hilton JF, Dodd CL, Greenspan D. Prophylaxis with nystatin pastilles for HIV-associated oral candidiasis. J Acquir Immune Defic Syndr Hum Retrovirol. 1996 Aug 15;12(5):470-6.

Study ID Numbers:  026B; 5
Record last reviewed:  August 2004
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002293
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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December 5, 2009



Page Updated: June 1, 2005
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