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.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00002293
First received: November 2, 1999
Last updated: October 1, 2007
Last verified: October 2007

November 2, 1999
October 1, 2007
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Complete list of historical versions of study NCT00002293 on ClinicalTrials.gov Archive Site
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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
Nystatin Pastille for the Prophylaxis of Oral Candidiasis in Patients With AIDS or AIDS Related Syndromes

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)

Not Provided
Interventional
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Primary Purpose: Treatment
  • Candidiasis, Oral
  • HIV Infections
Drug: Nystatin
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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.
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002293
026B, 5
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Bristol-Myers Squibb
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Bristol-Myers Squibb
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP