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 @ 6:29 PM
Ignite Modification Date:
2025-12-24 @ 6:29 PM
NCT ID:
NCT00002068
Eligibility Criteria:
Inclusion Criteria
Concurrent Medication:
Allowed:
* Immunosuppressant therapy.
* Antiviral therapy such as zidovudine.
* Prophylaxis for Pneumocystis carinii pneumonia.
Concurrent Treatment:
Allowed:
* Radiation therapy for mucocutaneous Kaposi's sarcoma.
Written informed consent must be obtained for each patient, either from the patient himself or from the patient's legal guardian.
* No prior systemic antifungal therapy for cryptococcosis.
* Relapse after prior therapy.
* Success of prior therapy must have been documented by negative cerebrospinal fluid (CSF) culture at the end of therapy. Following prior therapy, such patients may not have received more than 1 mg/kg/wk amphotericin B in the 4 weeks before entry into study.
Prior Medication:
Allowed:
* Immunosuppressant therapy.
* Antiviral therapy such as zidovudine.
* Prophylaxis for Pneumocystis carinii pneumonia.
Exclusion Criteria
Co-existing Condition:
Patients with the following are excluded:
* Evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis.
* History of allergy to or intolerance of imidazoles, azoles, or amphotericin B.
* Moderate or severe liver disease.
* Comatose.
* Unlikely to survive more than 2 weeks.
Concurrent Medication:
Excluded within 4 weeks of study entry:
* Greater than 1 mg/kg/wk amphotericin B.
* Coumadin-type anticoagulants.
* Oral hypoglycemics.
* Barbiturates.
* Phenytoin.
* Immunostimulants.
* Investigational drugs or approved (licensed) drugs for investigational indications.
Concurrent Treatment:
Excluded:
* Lymphocyte replacement.
Patients with the following are excluded:
* Evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis.
* History of allergy to or intolerance of imidazoles, azoles, or amphotericin B.
* Moderate or severe liver disease.
* Comatose.
* Unlikely to survive more than 2 weeks.
Prior Medication:
Excluded within 4 weeks of study entry:
* Greater than 1 mg/kg/wk amphotericin B.
* Coumadin-type anticoagulants.
* Oral hypoglycemics.
* Barbiturates.
* Phenytoin.
* Immunostimulants.
* Investigational drugs or approved (licensed) drugs for investigational indications.
Prior Treatment:
Excluded:
* Lymphocyte replacement.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Study:
NCT00002068
Study Brief:
Protocol Section:
NCT00002068