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CompletedNCT00002293Updated Oct 2, 2007

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

An interventional study of Nystatin in Candidiasis, Oral and HIV Infections, sponsored by Bristol-Myers Squibb. Completed at 2 sites in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2007-10-02.

Sponsored by Bristol-Myers Squibb · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Ages
12 Years and older
Sex
All
01

Study summary

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)

02

Conditions studied

  • Candidiasis, Oral
  • HIV Infections

Keywords

  • Nystatin
  • AIDS-Related Opportunistic Infections
  • Acquired Immunodeficiency Syndrome
  • AIDS-Related Complex
  • Candidiasis, Oral
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

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Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment

Interventions

  • DrugNystatin
06

Study locations

2 sites
  • Birmingham Veterans Administration Med Ctr / Univ of Alabama
    Birmingham, Alabama 35233, United States
  • Bristol - Myers Squibb Co
    Princeton, New Jersey 085434000, United States
07

References and documents

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. doi: 10.1097/00042560-199608150-00005. PubMed 8757423 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 2, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00002293
Lead sponsor
Bristol-Myers Squibb
First posted
Aug 31, 2001
Last update
Oct 2, 2007
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2007. You cannot join it, but the record below documents what was studied.

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