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

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	October 1, 2007
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00002293 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	A Study of Nystatin in the Prevention of Fungal Infections of the Mouth in Patients With AIDS or AIDS-Related Syndromes
Official Title ^ICMJE	Nystatin Pastille for the Prophylaxis of Oral Candidiasis in Patients With AIDS or AIDS Related Syndromes
Brief 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)
Detailed Description
Study Phase
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Dose Comparison
Condition ^ICMJE	Candidiasis, Oral HIV Infections
Intervention ^ICMJE	Drug: Nystatin
Study Arms / Comparison Groups
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.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	12 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00002293
Responsible Party
Study ID Numbers ^ICMJE	026B, 5
Study Sponsor ^ICMJE	Bristol-Myers Squibb
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Bristol-Myers Squibb
Verification Date	October 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP