A Study of Nystatin in the Prevention of Fungal Infection... | NCT00002293

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

NCT00002293

Sponsor

Bristol-Myers Squibb

Status

Completed

Last Update Posted

Oct 2, 2007Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Candidiasis, Oral
HIV Infections

Interventions

Nystatin

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
5

Status Module

Record Verification Date

Oct 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Nov 2, 1999

First Submission Date that Met QC Criteria

Aug 30, 2001

First Posted Date

Aug 31, 2001Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 1, 2007

Last Update Posted Date

Oct 2, 2007Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Nystatin	Drug

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Birmingham Veterans Administration Med Ctr / Univ of Alabama		Birmingham	Alabama	35233	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
8757423	Background	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. doi: 10.1097/00042560-199608150-00005.

ID	Term
D002180	Candidiasis, Oral
D015658	HIV Infections
D017088	AIDS-Related Opportunistic Infections
D000163	Acquired Immunodeficiency Syndrome
D000386	AIDS-Related Complex

ID	Term
D002177	Candidiasis
D009181	Mycoses
D001423	Bacterial Infections and Mycoses
D007239	Infections

ID	Term
D018942	Macrolides
D007783	Lactones
D009930	Organic Chemicals