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Trial NCT00000849

Resource URI: http://static.linkedct.org/resource/trials/NCT00000849
PropertyValue
linkedct:brief_title A Study to Test the Safety of Recombinant Interleukin-2 (rIL-2) in HIV-Infected Children
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/2560>
linkedct:condition <http://static.linkedct.org/resource/condition/5486>
linkedct: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.
linkedct: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.]
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 12 Years
linkedct:eligibility_minimum_age 3 Years
linkedct:enrollment 27 (xsd:int)
linkedct:firstreceived_date November 2, 1999
linkedct:id NCT00000849
rdfs:label Trial NCT00000849
linkedct:lastchanged_date July 29, 2008
linkedct:lead_sponsor_agency National Institute of Allergy and Infectious Diseases (NIAID)
linkedct:location <http://static.linkedct.org/resource/location/147780>
linkedct:location <http://static.linkedct.org/resource/location/152982>
linkedct:location <http://static.linkedct.org/resource/location/153882>
linkedct:location <http://static.linkedct.org/resource/location/153995>
linkedct:location <http://static.linkedct.org/resource/location/160320>
linkedct:location <http://static.linkedct.org/resource/location/164443>
linkedct:location <http://static.linkedct.org/resource/location/171716>
linkedct:location <http://static.linkedct.org/resource/location/192981>
linkedct:location <http://static.linkedct.org/resource/location/193168>
linkedct:location <http://static.linkedct.org/resource/location/197412>
linkedct:location <http://static.linkedct.org/resource/location/202102>
linkedct:location <http://static.linkedct.org/resource/location/205665>
linkedct:location <http://static.linkedct.org/resource/location/211745>
linkedct:location <http://static.linkedct.org/resource/location/216582>
linkedct:nct_id NCT00000849
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Phase I/II Trial of Recombinant Interleukin-2 In Symptomatic Human Immunodeficiency Virus-Infected Children
linkedct:org_study_id ACTG 299
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/56005>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/56437>
linkedct:overall_status Active, not recruiting
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000849>
linkedct:phase Phase 1
linkedct:reference <http://static.linkedct.org/resource/reference/26109>
linkedct:secondary_id PACTG 299
linkedct:source National Institute of Allergy and Infectious Diseases (NIAID)
linkedct:study_design Treatment, Randomized, Safety Study
linkedct:study_type Interventional
linkedct: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.
rdf:type linkedct:trials
linkedct:verification_date August 2004