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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• • 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.

Trial Officials