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 @ 9:32 PM
Ignite Modification Date:
2025-12-24 @ 9:32 PM
NCT ID:
NCT00002132
Eligibility Criteria:
Inclusion Criteria
Patients must have:
* Esophageal candidiasis.
* Histological evidence of Candida spp. at baseline with confirmation by positive mycological culture.
* HIV infection or other predisposing risk factor.
* Life expectancy of at least 2 months.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
* Malignancies of the head or neck, if the treatment or disease will interfere with response assessment.
* Evidence of systemic fungal infection.
* Underlying clinical condition that would preclude study completion.
* Judged to be unreliable in regard to following physician's directives.
Concurrent Medication:
Excluded:
* Rifampin.
* Rifabutin.
* Phenobarbital.
* Phenytoin.
* Carbamazepine.
* Terfenadine.
* Astemizole.
* H2 blockers.
* Continual antacids.
* Any investigational drug (expanded access drugs are allowed).
Patients with the following prior conditions are excluded:
* History of significant hepatic abnormalities or clinical evidence of hepatic disease within 2 months prior to study entry.
* History of hypersensitivity to imidazole or azole compounds.
Prior Medication:
Excluded:
* Other orally administered antifungal therapy within 3 days prior to study entry.
* Any investigational drug within 1 month prior to study entry (expanded access drugs are allowed).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Study:
NCT00002132
Study Brief:
Protocol Section:
NCT00002132