A Study to Test the Safety of Recombinant Interleukin-2 (rIL-2) in HIV-Infected Children
NCT ID: NCT00000849
Last Updated: 2021-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
27 participants
INTERVENTIONAL
2001-03-31
Brief Summary
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IL-2 is a substance naturally produced by the body's white blood cells that plays an important role in helping the body fight infection. HIV-infected patients do not produce enough IL-2, and it is hoped that the use of rIL-2 may improve immune system function in these patients. First, it is necessary to determine the safety and effectiveness of this drug in HIV-infected children.
Detailed Description
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Part A: Children will receive rIL-2 intravenously for 5 days every 8 weeks for 3 cycles. The study will enroll 4 patients in each of 3 dose levels. Dose escalation may occur if all 4 patients in a dose level tolerate therapy without evidence of Grade 3 (or higher) toxicity. If 1 of 4 subjects in any dose level experiences at least Grade 3 toxicity, 2 additional patients will be enrolled in that dose level. If 1 of these 2 additional patients experiences at least Grade 3 toxicity, dose escalation will not proceed. NOTE: Once Part A is completed and the maximum tolerated dose is established, children who participated in Part A and received less than the maximum tolerated dose will be offered additional therapy consisting of 3 cycles of rIL-2 at the maximum tolerated dose.
Part B: Children will receive rIL-2 intravenously at the maximum tolerated dose established in part A. Treatment will be given for 5 days every 8 weeks for 3 cycles. \[AS PER AMENDMENT 6/4/98: Children will receive rIL-2 intravenously at the lowest dose for 5 days every 8 weeks for 6 cycles. Patients who received this dose in part A will also be offered this regimen.\]
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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Aldesleukin
Eligibility Criteria
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Inclusion Criteria
* 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
* Have an active opportunistic infection.
* Are pregnant.
3 Years
12 Years
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Stuart Starr
Role: STUDY_CHAIR
Steven Douglas
Role: STUDY_CHAIR
Locations
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Long Beach Memorial Med. Ctr., Miller Children's Hosp.
Long Beach, California, United States
UCSF Pediatric AIDS CRS
San Francisco, California, United States
Univ. of Colorado Denver NICHD CRS
Aurora, Colorado, United States
Univ. of Florida Jacksonville NICHD CRS
Jacksonville, Florida, United States
Chicago Children's CRS
Chicago, Illinois, United States
Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
Chicago, Illinois, United States
Tulane/LSU Maternal/Child CRS
New Orleans, Louisiana, United States
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
Boston, Massachusetts, United States
NYU Med. Ctr., Dept. of Medicine
New York, New York, United States
Columbia IMPAACT CRS
New York, New York, United States
Incarnation Children's Ctr.
New York, New York, United States
The Children's Hosp. of Philadelphia IMPAACT CRS
Philadelphia, Pennsylvania, United States
Texas Children's Hosp. CRS
Houston, Texas, United States
VCU Health Systems, Dept. of Peds
Richmond, Virginia, United States
Countries
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References
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Zeng C, Mawhinney S, Baron AE, McFarland EJ. Evaluating ELISPOT summary measures with criteria for obtaining reliable estimates. J Immunol Methods. 2005 Feb;297(1-2):97-108. doi: 10.1016/j.jim.2004.12.006.
Other Identifiers
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11275
Identifier Type: REGISTRY
Identifier Source: secondary_id
PACTG 299
Identifier Type: -
Identifier Source: secondary_id
ACTG 299
Identifier Type: -
Identifier Source: org_study_id