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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.
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
  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

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Nystatin Pastille for the Prophylaxis of Oral Candidiasis in Patients With AIDS or AIDS Related Syndromes

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00002293     History of Changes
Other Study ID Numbers: 026B, 5
Study First Received: November 2, 1999
Last Updated: October 1, 2007
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

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Candidiasis
Candidiasis, Oral
Communicable Diseases
HIV Infections
Infection
Syndrome
Disease
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Mouth Diseases
Mycoses
Pathologic Processes
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Stomatognathic Diseases
Virus Diseases
Nystatin
Anti-Bacterial Agents
Anti-Infective Agents
Antifungal Agents
Ionophores
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014