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:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-25 @ 2:50 AM
NCT ID:
NCT00002133
Eligibility Criteria:
Inclusion Criteria
Patients must have:
* HIV antibody seropositivity or diagnosis of AIDS.
* Confirmed oropharyngeal candidiasis.
* Failed fluconazole treatment within the past 14 days.
* Life expectancy of at least 3 months.
* NO symptoms of esophageal candidiasis (e.g., dysphagia) unless endoscopic exam of esophagus was performed and fungal esophagitis was not present.
* NO prior disseminated candidiasis.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
* Underlying clinical condition that precludes study completion or places the patient at significant risk.
* Considered unreliable about following physician's directives.
Concurrent Medication:
Excluded:
* Investigational drugs (approved expanded access drugs are permitted).
* Rifampin.
* Rifabutin.
* Phenobarbital.
* Phenytoin.
* Carbamazepine.
* Terfenadine.
* Astemizole.
Patients with the following prior conditions are excluded:
* History of hypersensitivity to imidazole or azole compounds.
* Clinical evidence of significant hepatic disease within the past 2 months.
Prior Medication:
Excluded:
* Investigational drugs within 1 month prior to study entry (approved expanded access drugs are permitted).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00002133
Study Brief:
Protocol Section:
NCT00002133