A Treatment IND for Retrovir Brand Zidovudine (AZT) Therapy of Pediatric Patients With HIV Disease

Inclusion Criteria Concurrent Treatment: Allowed: Blood transfusions for hematologic toxicity. Criteria for children 3 months to less than 15 months of age: Patient must be HIV antibody-positive by repeated reactive screening test (e.g., ELISA) and positive confirmatory test (e.g., Western blot). OR If antibody-negative, patient must have two positive p24 antigen determinations performed at least one week apart or have had a positive HIV culture. Patients must meet two of the following criteria: Be HIV culture positive or p24 antigen positive. Have at least one of the Class P-2 symptoms (by CDC criteria). Be immunosuppressed defined as having: CD4+(T4) lymphocytes = or < 400 cells/mm3. Abnormal age adjusted immunoglobulin levels (IgG or IgA). Decreased helper/suppressor ratio < 1.0. Note: In general, abnormal values for any of the above lab tests should be confirmed in 2 measurements at least 1 week apart, and other clinical causes for these abnormalities should be ruled out. Criteria for children 15 months to 12 years of age: Patient must be HIV antibody-positive by repeated reactive screening test (e.g., ELISA) and positive confirmatory test (e.g., Western blot). OR If antibody-negative, patient must have two positive p24 antigen determinations performed at least one week apart or have had a positive HIV culture. Patients must meet one of the following criteria: Have at least one of the class P-2 symptoms (by CDC criteria). Be immunosuppressed defined as having CD4+(T4) lymphocytes = or < 400 cells/mm3, based on two measurements at least 1 week apart. Exclusion Criteria Co-existing Condition: Patients with known hypersensitivity to AZT are excluded. Patients with the following are excluded: Failure to meet inclusion criteria. Inability to obtain signed informed consent from a parent or legal guardian. Enrollment in another treatment protocol that expressly prohibits concomitant treatment with zidovudine (AZT). Enrollment in another clinical trial in which AZT is a treatment. Known hypersensitivity to AZT.