A Study to Test the Safety of Recombinant Interleukin-2 (rIL-2) in HIV-Infected Children
Information source: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Aldesleukin (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID) Official(s) and/or principal investigator(s): Stuart Starr, Study Chair Steven Douglas, Study Chair
Summary
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.
Clinical Details
Official title: Phase I/II Trial of Recombinant Interleukin-2 In Symptomatic Human Immunodeficiency Virus-Infected Children
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Primary Purpose: Treatment
Detailed description:
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.]
Eligibility
Minimum age: 3 Years.
Maximum age: 12 Years.
Gender(s): Both.
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.
Locations and Contacts
Long Beach Memorial Med. Ctr., Miller Children's Hosp., Long Beach, California 90801, United States
UCSF Pediatric AIDS CRS, San Francisco, California 941430105, United States
Univ. of Colorado Denver NICHD CRS, Aurora, Colorado 802181088, United States
Univ. of Florida Jacksonville NICHD CRS, Jacksonville, Florida 32209, United States
Chicago Children's CRS, Chicago, Illinois 606143394, United States
Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease, Chicago, Illinois 606371470, United States
Tulane/LSU Maternal/Child CRS, New Orleans, Louisiana 701122699, United States
HMS - Children's Hosp. Boston, Div. of Infectious Diseases, Boston, Massachusetts 021155724, United States
Columbia IMPAACT CRS, New York, New York 10032, United States
Incarnation Children's Ctr., New York, New York 10032, United States
NYU Med. Ctr., Dept. of Medicine, New York, New York 10016, United States
The Children's Hosp. of Philadelphia IMPAACT CRS, Philadelphia, Pennsylvania 191044318, United States
Texas Children's Hosp. CRS, Houston, Texas 77030, United States
VCU Health Systems, Dept. of Peds, Richmond, Virginia 23219, United States
Additional Information
Click here for more information about aldesleukin Haga clic aquí para ver información sobre este ensayo clínico en español.
Related publications: Zeng C, Mawhinney S, Barón AE, McFarland EJ. Evaluating ELISPOT summary measures with criteria for obtaining reliable estimates. J Immunol Methods. 2005 Feb;297(1-2):97-108.
Last updated: May 17, 2012
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