A Phase I Study of the Safety and Pharmacokinetics of Recombinant CD4 (rCD4) in Infants and Children Infected With or at Risk for HIV Infection

Exclusion Criteria

• •All patients must have:
• •A life expectancy of at least 3 months.
• •A legally-qualified guardian with the ability to sign a written informed consent form, which must be obtained prior to treatment. A willingness to abstain from all other experimental therapy for HIV infection during the entire study period.
• •Concurrent Medication:
• •Excluded:
• •Zidovudine (AZT).
• •Intravenous gamma globulin (IVIG).
• •Pentamidine.
• •Trimethoprim / sulfamethoxazole (TMP/SMX).
• •Corticosteroids.
• •Nonsteroidal anti-inflammatory agents (NSAIDS).
• •Other known immunomodulatory agents.
• •All other experimental therapies.
• •Patients will be excluded from the study for the following reasons:
• •Serious active opportunistic infection or malignancies prior to study entry.
• •Defined organ insufficiencies.
• •Prior Medication:
• •Excluded within 3 weeks of study entry:
• •Zidovudine (AZT).
• •Intravenous gamma globulin.
• •Cancer chemotherapy.
• •Immunomodulatory agents.
• •Other experimental therapy.
• •Patients may not have any of the following diseases or symptoms:
• •Serious active opportunistic infection or malignancies prior to study entry.
• •Cardiopathy.
• •Two or more episodes of prior Pneumocystis carinii pneumonia (PCP).
• •Hematologic insufficiency defined as granulocytes = or \< 1000 cells/mm3; platelets = or \< 100000 cells/mm3; hemoglobin = or \< 8 g/dl.
• •Renal insufficiency defined as creatinine \> 2 mg/dl; = or \> 5 white blood cells or red blood cells/hpf or = or \> 2+ proteinuria in urine.
• •Hepatic insufficiency defined as bilirubin = or \> 3 x upper limit of normal; SGOT = or \> 10 upper limit of normal.