- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00000849
A Study to Test the Safety of Recombinant Interleukin-2 (rIL-2) in HIV-Infected Children
Phase I/II Trial of Recombinant Interleukin-2 In Symptomatic Human Immunodeficiency Virus-Infected Children
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.
Study Overview
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.]
Study Type
Enrollment
Phase
- Phase 1
Contacts and Locations
Study Locations
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California
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Long Beach, California, United States, 90801
- Long Beach Memorial Med. Ctr., Miller Children's Hosp.
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San Francisco, California, United States, 941430105
- UCSF Pediatric AIDS CRS
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Colorado
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Aurora, Colorado, United States, 802181088
- Univ. of Colorado Denver NICHD CRS
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Florida
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Jacksonville, Florida, United States, 32209
- Univ. of Florida Jacksonville NICHD CRS
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Illinois
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Chicago, Illinois, United States, 606143394
- Chicago Children's CRS
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Chicago, Illinois, United States, 606371470
- Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
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Louisiana
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New Orleans, Louisiana, United States, 701122699
- Tulane/LSU Maternal/Child CRS
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Massachusetts
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Boston, Massachusetts, United States, 021155724
- HMS - Children's Hosp. Boston, Div. of Infectious Diseases
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New York
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New York, New York, United States, 10032
- Columbia IMPAACT CRS
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New York, New York, United States, 10016
- NYU Med. Ctr., Dept. of Medicine
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New York, New York, United States, 10032
- Incarnation Children's Ctr.
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 191044318
- The Children's Hosp. of Philadelphia IMPAACT CRS
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Texas
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Houston, Texas, United States, 77030
- Texas Children's Hosp. CRS
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Virginia
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Richmond, Virginia, United States, 23219
- VCU Health Systems, Dept. of Peds
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Stuart Starr
- Study Chair: Steven Douglas
Publications and helpful links
Study record dates
Study Major Dates
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Anti-Infective Agents
- Antiviral Agents
- Anti-HIV Agents
- Anti-Retroviral Agents
- Antineoplastic Agents
- Aldesleukin
Other Study ID Numbers
- ACTG 299
- 11275 (Registry Identifier: DAIDS ES Registry Number)
- PACTG 299
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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