Nystatin Pastilles for the Prevention of Oral Candidiasis in Patients With AIDS or ARC
Nystatin
Blood-Borne Infections+22
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
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).
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 12 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Birmingham Veterans Administration Med Ctr / Univ of Alabama
Birmingham, United StatesOpen Birmingham Veterans Administration Med Ctr / Univ of Alabama in Google MapsBristol - Myers Squibb Co
Princeton, United States