A Study to Test the Safety of Recombinant Interleukin-2 (rIL-2) in HIV-Infected Children
Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001
Trial Information
Current as of May 09, 2025
Completed
Keywords
ClinConnect Summary
According to study records, IL-2 has not been tested in HIV-infected children. Experience with IL-2 in pediatric populations is extremely limited. Pahwa et al. gave 30,000 units/kg daily IV to a child with severe combined immunodeficiency. This dose was well tolerated and the patient improved clinically as well as immunologically. Part A is necessary to determine the maximum tolerated dose of IL-2 in infected children. Part B will determine the efficacy of the maximum tolerated dose in infected children.
Part A: Children will receive rIL-2 intravenously for 5 days every 8 weeks for 3 cycle...
Gender
ALL
Eligibility criteria
- • Inclusion Criteria
- Children may be eligible for this study if they:
- • Are HIV-positive.
- • Have decreased immune system functioning (CD4 count 500-1000 for 3- to 5-year-olds or CD4 count 200-500 for 6- to 12-year-olds).
- • Have symptomatic HIV infection.
- • Have a viral level less than 400 copies/ml.
- • Are between the ages of 3 and 12 (consent of parent or guardian required).
- • Exclusion Criteria
- Children will not be eligible for this study if they:
- • Have an active opportunistic infection.
- • Are pregnant.
About National Institute Of Allergy And Infectious Diseases (Niaid)
The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
New Orleans, Louisiana, United States
Boston, Massachusetts, United States
New York, New York, United States
San Francisco, California, United States
Chicago, Illinois, United States
New York, New York, United States
Houston, Texas, United States
Long Beach, California, United States
Aurora, Colorado, United States
Jacksonville, Florida, United States
Chicago, Illinois, United States
New York, New York, United States
Philadelphia, Pennsylvania, United States
Richmond, Virginia, United States
Patients applied
Trial Officials
Stuart Starr
Study Chair
Steven Douglas
Study Chair
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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