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OpenTrials
Completed

NCT Number: NCT00002057

Nystatin Pastilles for the Prevention of Oral Candidiasis in Patients With AIDS or ARC

To determine a safe, effective, and convenient dosing schedule for nystatin pastilles in the prevention of oral candidiasis in patients with AIDS or AIDS related complex (ARC) (group III or IV, CDC classification).

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Key information

Conditions

Candidiasis, Oral AIDS-Related Complex AIDS-Related Opportunistic Infections Acquired Immunodeficiency Syndrome Bacterial Infections and Mycoses Blood-Borne Infections Candidiasis Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mouth Diseases Mycoses Opportunistic Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Stomatognathic Diseases Urogenital Diseases Virus Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Concurrent Medication:

Allowed:

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

Patients with the following conditions are included:

  • AIDS or AIDS related complex (ARC) (HIV infection Group 3 or 4, CDC classification) who have had culture-proven oral candidiasis clinically cured within 7 days of study entry and are likely to be compliant for the 20 weeks of nystatin pastille prophylaxis.
  • Able to follow instructions regarding the use of a pastille.
  • Patients entering part II of this study (randomized double-blind) must have been clinically cured of oral candidiasis within 1 - 7 days of entry into this randomized study.
  • Oral lesions such as Kaposi's sarcoma, herpes zoster, and herpes simplex can be enrolled.

Exclusion criteria

Co-existing Condition:

Patients with the following are excluded:

  • Systemic candidiasis.
  • Hypersensitivity to nystatin.
  • Suspected or proven candidal esophagitis.

Patients with the following are excluded:

  • Systemic candidiasis.
  • Projected survival of less than 6 months.
  • Unable to maintain a pastille in the buccal cavity for approximately 20 minutes twice a day.
  • Hypersensitivity to nystatin.
  • Suspected or proven candidal esophagitis.

Treatment and study plan

Nystatin

Drug

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Important dates

First posted
Aug 31, 2001
Registry last updated
Oct 2, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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