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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

Page last updated: August 23, 2015

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