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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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).

Detailed Description

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Conditions

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Candidiasis, Oral HIV Infections

Keywords

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Nystatin AIDS-Related Opportunistic Infections Acquired Immunodeficiency Syndrome AIDS-Related Complex Candidiasis, Oral

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Nystatin

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Birmingham Veterans Administration Med Ctr / Univ of Alabama

Birmingham, Alabama, United States

Site Status

Bristol - Myers Squibb Co

Princeton, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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4

Identifier Type: -

Identifier Source: secondary_id

026A