Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2025-12-24 @ 6:43 PM
NCT ID:
NCT00002057
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT00002057
Study Brief:
Protocol Section:
NCT00002057