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NCT00000849 Clinical Trial

A Study to Test the Safety of Recombinant Interleukin-2 (rIL-2) in HIV-Infected Children

HIV Infections Clinical Trial

Official title:
Phase I/II Trial of Recombinant Interleukin-2 In Symptomatic Human Immunodeficiency Virus-Infected Children

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00000849
Other study ID # ACTG 299
Secondary ID 11275PACTG 299
Status Completed
Phase Phase 1
First received
Last updated
Est. completion date March 2001

Study information
Verified date October 2021
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.]

Recruitment information / eligibility
Status Completed
Enrollment 27
Est. completion date March 2001
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 3 Years to 12 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Aldesleukin

Locations
Country Name City State
United States Univ. of Colorado Denver NICHD CRS Aurora Colorado
United States HMS - Children's Hosp. Boston, Div. of Infectious Diseases Boston Massachusetts
United States Chicago Children's CRS Chicago Illinois
United States Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease Chicago Illinois
United States Texas Children's Hosp. CRS Houston Texas
United States Univ. of Florida Jacksonville NICHD CRS Jacksonville Florida
United States Long Beach Memorial Med. Ctr., Miller Children's Hosp. Long Beach California
United States Tulane/LSU Maternal/Child CRS New Orleans Louisiana
United States Columbia IMPAACT CRS New York New York
United States Incarnation Children's Ctr. New York New York
United States NYU Med. Ctr., Dept. of Medicine New York New York
United States The Children's Hosp. of Philadelphia IMPAACT CRS Philadelphia Pennsylvania
United States VCU Health Systems, Dept. of Peds Richmond Virginia
United States UCSF Pediatric AIDS CRS San Francisco California

Sponsors (2)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

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