Nystatin Pastilles for the Prevention of Oral Candidiasis in Patients With AIDS or ARC - Full Text View

Purpose

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).

Condition	Intervention
Candidiasis, Oral HIV Infections	Drug: Nystatin

MedlinePlus related topics:

AIDS Yeast Infections

Drug Information available for:

Nystatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Dose Comparison

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

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002057

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

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

Study ID Numbers:	026A, 4
First Received:	November 2, 1999
Last Updated:	October 1, 2007
ClinicalTrials.gov Identifier:	NCT00002057
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

Study placed in the following topic categories:

Mouth Diseases

Opportunistic Infections

Candidiasis, Oral

Sexually Transmitted Diseases, Viral

Candidiasis

Clotrimazole

Miconazole

Acquired Immunodeficiency Syndrome

Tioconazole

Nystatin

AIDS-Related Complex

Immunologic Deficiency Syndromes

Virus Diseases

Mycoses

HIV Infections

AIDS-Related Opportunistic Infections

Sexually Transmitted Diseases

Stomatognathic Diseases

Retroviridae Infections

Additional relevant MeSH terms:

Anti-Infective Agents

RNA Virus Infections

Slow Virus Diseases

Immune System Diseases

Molecular Mechanisms of Pharmacological Action

Infection

Pharmacologic Actions

Membrane Transport Modulators

Anti-Bacterial Agents

Antifungal Agents

Therapeutic Uses

Lentivirus Infections

Ionophores

ClinicalTrials.gov processed this record on December 03, 2008

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00002057