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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000849 |
The purpose of this study is to determine the safety and maximum tolerated dose (the highest dose that can be given safely) of recombinant Interleukin-2 (rIL-2) in HIV-infected children. This study also evaluates the effect of rIL-2 on the immune system of these patients.
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.
Condition | Intervention | Phase |
HIV Infections |
Drug: Aldesleukin |
Phase I |
MedlinePlus related topics: | AIDS |
Drug Information available for: | Aldesleukin Interleukin-2 |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Safety Study |
Official Title: | Phase I/II Trial of Recombinant Interleukin-2 In Symptomatic Human Immunodeficiency Virus-Infected Children |
Estimated Enrollment: | 27 |
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 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.]
Ages Eligible for Study: | 3 Years to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Children may be eligible for this study if they:
Exclusion Criteria
Children will not be eligible for this study if they:
United States, California | |||||
UCSF / Moffitt Hosp - Pediatric | |||||
San Francisco, California, United States, 941430105 | |||||
Long Beach Memorial (Pediatric) | |||||
Long Beach, California, United States, 90801 | |||||
United States, Colorado | |||||
Children's Hosp of Denver | |||||
Denver, Colorado, United States, 802181088 | |||||
United States, Florida | |||||
Univ of Florida Health Science Ctr / Pediatrics | |||||
Jacksonville, Florida, United States, 32209 | |||||
United States, Illinois | |||||
Chicago Children's Memorial Hosp | |||||
Chicago, Illinois, United States, 606143394 | |||||
Univ of Chicago Children's Hosp | |||||
Chicago, Illinois, United States, 606371470 | |||||
United States, Louisiana | |||||
Tulane Univ / Charity Hosp of New Orleans | |||||
New Orleans, Louisiana, United States, 701122699 | |||||
United States, Massachusetts | |||||
Children's Hosp of Boston | |||||
Boston, Massachusetts, United States, 021155724 | |||||
United States, New York | |||||
Bellevue Hosp / New York Univ Med Ctr | |||||
New York, New York, United States, 10016 | |||||
Columbia Presbyterian Med Ctr | |||||
New York, New York, United States, 10032 | |||||
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr | |||||
New York, New York, United States, 10032 | |||||
United States, Pennsylvania | |||||
Children's Hosp of Philadelphia | |||||
Philadelphia, Pennsylvania, United States, 191044318 | |||||
United States, Texas | |||||
Texas Children's Hosp / Baylor Univ | |||||
Houston, Texas, United States, 77030 | |||||
United States, Virginia | |||||
Med College of Virginia | |||||
Richmond, Virginia, United States, 23219 |
National Institute of Allergy and Infectious Diseases (NIAID) |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
Study Chair: | Stuart Starr | |
Study Chair: | Steven Douglas |
Click here for more information about aldesleukin 
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Haga clic aquí para ver información sobre este ensayo clínico en español. 
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Study ID Numbers: | ACTG 299, PACTG 299 |
First Received: | November 2, 1999 |
Last Updated: | July 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00000849 |
Health Authority: | United States: Federal Government |
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