Phase I/II Study of Recombinant Human Interferon-gamma (rIFN-gamma) in HIV-Infected Children

It is likely that infants and children severely immunocompromised by HIV infection would respond to immunomodulators that augment different portions of the host defense system. Interferon-gamma has been shown to benefit children with severely compromised nonspecific immunity and may thus be of benefit to those with HIV infection.

Patients are treated with subcutaneous rIFN-gamma 3 times a week for 24 weeks and are then followed for an additional 12 weeks.

Inclusion criteria

Concurrent Medication:

Required:

• AZT or ddI therapy.
• PCP prophylaxis.

Allowed:

• Antipyretics.
• Antiemetics.
• Antihistamines.
• Decongestants.
• Skin creams and lotions.
• Immunizations according to current recommendations.

Patients must have:

• Class P-2 symptomatic HIV infection.
• Ongoing AZT or ddI therapy of 6 months or longer duration.

Exclusion criteria

Concurrent Medication:

Excluded:

• Antiretroviral therapy other than AZT or ddI.
• Chemotherapy for active malignancy.
• Amphotericin B for systemic fungal infections.

Patients with the following prior conditions are excluded:

• History of congestive heart failure or arrhythmias.
• History of congenital heart disease.
• History of seizure disorder requiring anticonvulsant medication. (NOTE:

History of uncomplicated febrile seizures does not exclude.)

Prior Medication:

Excluded within 8 weeks prior to study entry:

• Immunomodulators other than IVIG.

Prior Treatment:

Excluded:

• Red blood cell transfusion within 4 weeks prior to study entry.

Required:

• Ongoing AZT or ddI therapy of 6 weeks or longer duration.
• Ongoing PCP prophylaxis for more than 6 weeks duration.

Ongoing alcohol or drug use.