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 @ 12:56 PM
Ignite Modification Date:
2025-12-24 @ 12:56 PM
NCT ID:
NCT00000961
Eligibility Criteria:
Inclusion Criteria
Concurrent Medication:
Allowed:
* Recommended:
* Standard immunizations. Should repeat MMR 3 months after discontinuing study.
* Benadryl and/or aspirin.
* Pneumocystis carinii pneumonia prophylaxis.
* Systemic ketoconazole and acyclovir, or oral nystatin for acute therapy.
* Aerosol ribavirin for short-term treatment of RSV.
Concurrent Treatment:
Allowed:
* Blood transfusion.
Patients must have the following:
* Parent or guardian available to give written informed consent.
* Protocol requires prior Institutional Review Board (IRB) approval before any subject is entered into study.
Prior Medication:
Allowed:
* Gammaglobulin, intravenous (IV) or intramuscular (IM).
* Immunoglobulin, IV (IVIG).
* Maternal antiretroviral treatment during pregnancy.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
* Symptomatic of any class P-2 symptoms (except lymphadenopathy at time of study entry.
* Presence of serious acute infection requiring parenteral treatment at time of study entry.
Concurrent Medication:
Excluded:
* Prophylaxis for oral candidiasis or otitis media or other infections.
* Immunoglobulin therapy (except single dose or for hypogammaglobulinemia).
* Ketoconazole, acyclovir, or nystatin for prophylaxis.
Patients with the following are excluded:
* Symptomatic of any class P-2 symptoms (except lymphadenopathy at time of study entry.
* Presence of serious acute infection requiring parenteral treatment at time of study entry.
Prior Medication:
Excluded:
* Antiretroviral treatment or experimental treatment within 2 weeks of entry.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Day
Maximum Age:
3 Months
Study:
NCT00000961
Study Brief:
Protocol Section:
NCT00000961