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

Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Candidiasis, Oral; HIV Infections

Intervention: Nystatin (Drug)

Phase: N/A

Status: Completed

Sponsored by: Bristol-Myers Squibb

Summary

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).

Clinical Details

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

Study design: Primary Purpose: Treatment

Eligibility

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Birmingham Veterans Administration Med Ctr / Univ of Alabama, Birmingham, Alabama 35233, United States

Bristol - Myers Squibb Co, Princeton, New Jersey 085434000, United States

Additional Information

BMS Clinical Trials Disclosure

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


Last updated: October 1, 2007

Page last updated: August 23, 2015

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