Status:
COMPLETED
Phase I/II Study of Recombinant Human Interferon-gamma (rIFN-gamma) in HIV-Infected Children
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Genentech, Inc.
Conditions:
HIV Infections
Eligibility:
All Genders
1-17 years
Phase:
PHASE1
Brief Summary
PRIMARY: To determine the safety and toxicity of recombinant interferon gamma-1b ( rIFN-gamma ) in HIV-infected children receiving ongoing zidovudine ( AZT ) or didanosine ( ddI ) therapy. To document...
Detailed Description
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 be...
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
October 1 1997
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00000761
End Date
October 1 1997
Last Update
November 3 2021
Active Locations (2)
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1
The Children's Hosp. of Philadelphia IMPAACT CRS
Philadelphia, Pennsylvania, United States, 191044318
2
Texas Children's Hosp. CRS
Houston, Texas, United States, 77030