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.

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety