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 @ 3:03 AM
Ignite Modification Date:
2025-12-25 @ 3:03 AM
NCT ID:
NCT00000833
Eligibility Criteria:
Inclusion Criteria
Concurrent Medication:
Recommended:
* PCP prophylaxis.
Allowed:
* Acetaminophen for no more than 72 hours.
* Immunoglobulin.
* Corticosteroids.
* Erythropoietin.
* G-CSF and GM-CSF.
* Ethionamide or isoniazid for TB if no alternative available.
* Immunizations according to current recommendations.
Patients must have:
* HIV infection.
* Immunologic abnormality or clinical symptoms as detailed in the Disease Status field.
* No active AIDS-defining opportunistic infection or malignancy, no progressive encephalopathy attributable to HIV and no chronic persistent diarrhea.
* Consent of parent or guardian.
PER AMENDMENT 7/2/96:
* At least 2 of the 5 children in the older half of each cohort must have an ICD p24 antigen concentration \>= 70 pg/ml at screening.
Prior Medication:
Allowed:
* Up to 6 weeks of prior immunomodulator therapy.
* Maternal immunomodulator or antiretroviral therapy, including during pregnancy.
* Prior corticosteroids or intravenous immunoglobulin.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
* Current grade 3 or worse neuropathy/lower motor neuropathy.
* Clinical or laboratory grade 3 or worse toxicities.
* Active serious bacterial infection.
Concurrent Medication:
Excluded:
* Chemotherapy for active malignancy.
* Antiretrovirals other than study drugs.
* Immunomodulators unless specifically allowed.
Patients with the following prior condition are excluded:
* History of grade 3 or worse neuropathy/lower motor neuropathy.
Prior Medication:
Excluded:
* Prior ddI or oral ribavirin.
* Aerosolized ribavirin within 6 weeks prior to study entry.
* Antiretroviral or immunomodulator therapy (other than corticosteroids or IVIG) within 1 week prior to blood draws for study entry.
Ongoing drug or alcohol abuse.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Months
Maximum Age:
12 Years
Study:
NCT00000833
Study Brief:
Protocol Section:
NCT00000833