A Phase I Study of the Safety and Pharmacokinetics of Recombinant CD4 Immunoglobulin G (rCD4-IgG) in Infants and Children With Documented HIV-1 Infection

Inclusion Criteria

Patients must have the following:

• HIV-1 infection, or if less than 15 months old, born to mother with HIV-1 infection.
• Legally qualified guardian with the ability to sign a written, informed consent form.
• Willingness to abstain from all other experimental therapy for HIV-1 infection during the first 12 weeks of the study period.
• Anticipated life expectancy of at least 3 months.

Prior Medication:

Allowed:

• Prophylactic anti-Pneumocystis carinii pneumonia (PCP) or antifungal therapy.
• Gamma globulin as prophylaxis for measles and varicella.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

• Past or present history of neurological abnormalities including withdrawal syndrome or seizures.
• Past or present history of any serious active opportunistic infection including Pneumocystis carinii pneumonia (PCP).
• Echocardiogram values > 2 standard deviations from normal.
• Hematologic, renal, or hepatic insufficiency.

Concurrent Medication:

Excluded:

• Zidovudine (AZT).
• Intravenous gamma globulin (IVIG) except as prophylaxis for measles and varicella.
• Cancer chemotherapy.
• Corticosteroids.
• Other known immunomodulatory agents.
• Other experimental therapy not specifically allowed.

Patients with the following are excluded:

• Hematologic, renal, or hepatic insufficiency.
• Past or present history of any serious active opportunistic infection.

Prior Medication:

Excluded for a minimum of 3 weeks prior to study entry:

• Zidovudine (AZT).
• Intravenous gamma globulin (IVIG).
• Cancer chemotherapy.
• Immunomodulatory agents.
• Acyclovir and other experimental therapy.

Risk Behavior:

Excluded:

• Patients born to substance abusing mothers (including alcohol) during the pregnancy.