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.