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 @ 1:01 PM
Ignite Modification Date:
2025-12-24 @ 1:01 PM
NCT ID:
NCT00000761
Eligibility Criteria:
Inclusion Criteria
Concurrent Medication:
Required:
* AZT or ddI therapy.
* PCP prophylaxis.
Allowed:
* Antipyretics.
* Antiemetics.
* Antihistamines.
* Decongestants.
* Skin creams and lotions.
* Immunizations according to current recommendations.
Patients must have:
* Class P-2 symptomatic HIV infection.
* Ongoing AZT or ddI therapy of 6 months or longer duration.
Exclusion Criteria
Concurrent Medication:
Excluded:
* Antiretroviral therapy other than AZT or ddI.
* Chemotherapy for active malignancy.
* Amphotericin B for systemic fungal infections.
Patients with the following prior conditions are excluded:
* History of congestive heart failure or arrhythmias.
* History of congenital heart disease.
* History of seizure disorder requiring anticonvulsant medication. (NOTE:
History of uncomplicated febrile seizures does not exclude.)
Prior Medication:
Excluded within 8 weeks prior to study entry:
* Immunomodulators other than IVIG.
Prior Treatment:
Excluded:
* Red blood cell transfusion within 4 weeks prior to study entry.
Required:
* Ongoing AZT or ddI therapy of 6 weeks or longer duration.
* Ongoing PCP prophylaxis for more than 6 weeks duration.
Ongoing alcohol or drug use.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
17 Years
Study:
NCT00000761
Study Brief:
Protocol Section:
NCT00000761