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 @ 4:22 PM
Ignite Modification Date:
2025-12-24 @ 4:22 PM
NCT ID:
NCT00001066
Eligibility Criteria:
Inclusion Criteria
Concurrent Medication:
Allowed:
* IVIG.
* Prophylaxis for opportunistic infection.
* EPO.
* G-CSF or GM-CSF.
Patients must have:
* Symptomatic HIV infection.
* Less than 56 days of prior antiretroviral therapy.
* Consent of parent or guardian.
NOTE:
* Co-enrollment on ACTG 219, ACTG 220, and certain ACTG opportunistic infection protocols is permitted.
Prior Medication:
Allowed:
* Up to 56 days of prior antiretroviral therapy.
* Prior immunomodulator therapy.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
* Malignancy.
* Hypersensitivity to a nucleoside analog.
* Current grade 2 or higher amylase/lipase toxicity or grade 3 or 4 other toxicity.
PER AMENDMENT 4/29/96:
* Active opportunistic infection and/or serious bacterial infection at the time of entry.
Concurrent Medication:
Excluded:
* Any other anti-HIV therapy.
* Megestrol acetate ( Megace ).
* Probenecid.
* IV pentamidine.
* Human growth hormone ( hGH ).
* Systemic corticosteroids for more than 2 weeks.
Prior Medication:
Excluded:
* Investigational drug therapy within 14 days prior to study entry.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Months
Maximum Age:
15 Years
Study:
NCT00001066
Study Brief:
Protocol Section:
NCT00001066