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To facilitate the use of zidovudine (AZT) in children who are 3 months to 12 years of age who are HIV-infected and either symptomatic or have a CD4 cell count < 400 cells/mm3 and to monitor adverse effects of AZT.
Previous studies with pediatric patients have shown improvements in clinical, immunologic, and virologic parameters with administration of AZT.
Full description
Previous studies with pediatric patients have shown improvements in clinical, immunologic, and virologic parameters with administration of AZT.
This Treatment IND (investigational new drug) is an open label, uncontrolled protocol. AZT is ordered and prescribed by the patient's physician. The physician is responsible for obtaining informed consent, assuring that the patient meets the eligibility criteria, dispensing the medication to the patient, monitoring the patient's condition on treatment, and reporting required data to the project coordinating center.
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Inclusion and exclusion criteria
Inclusion Criteria
Concurrent Treatment:
Allowed:
Criteria for children 3 months to less than 15 months of age:
OR
Patients must meet two of the following criteria:
Be immunosuppressed defined as having:
Note:
Criteria for children 15 months to 12 years of age:
OR
Patients must meet one of the following criteria:
Exclusion Criteria
Co-existing Condition:
Patients with known hypersensitivity to AZT are excluded.
Patients with the following are excluded:
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Data sourced from clinicaltrials.gov
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