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

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

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

Study Type:	Interventional
Study Design:	Treatment, Dose Comparison
Official Title:	Nystatin Pastilles for the Prevention of Oral Candidiasis in Patients With AIDS or ARC

Resource links provided by NLM:

MedlinePlus related topics: AIDS Yeast Infections

Drug Information available for: Nystatin

U.S. FDA Resources

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

Additional 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

No publications provided

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

Mouth Diseases
Communicable Diseases
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Candidiasis, Oral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Candidiasis
Nystatin
Infection
Membrane Transport Modulators
Anti-Bacterial Agents
Mycoses
Antifungal Agents

Therapeutic Uses
Retroviridae Infections
Ionophores
RNA Virus Infections
Immune System Diseases
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
Pharmacologic Actions
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Stomatognathic Diseases

ClinicalTrials.gov processed this record on February 08, 2010