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

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.

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