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

Inclusion Criteria Concurrent Medication: Allowed: Prophylactic medication for patients with previous documented episodes of Pneumocystis carinii pneumonia (PCP). Concomitant zidovudine (AZT) or intravenous gamma globulin (IVIG) during maintenance therapy phase of the study. AMENDED: As of 10/19/90 only Children 0 to 3 months are being enrolled. Original design: Patients must be infected with HIV or at risk for HIV infection. They must be one of the following: Asymptomatic. Mildly symptomatic but not eligible for and/or decline ACTG protocol 052. Markedly symptomatic but not eligible for and/or decline ACTG protocol 051 or cannot tolerate zidovudine (AZT) therapy. 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. Exclusion Criteria 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.