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

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.