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

Status

Completed

Conditions

Intervention / 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.]

Study Type

Interventional

Enrollment

27

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Long Beach, California, United States, 90801
        • Long Beach Memorial Med. Ctr., Miller Children's Hosp.
      • San Francisco, California, United States, 941430105
        • UCSF Pediatric AIDS CRS
    • Colorado
      • Aurora, Colorado, United States, 802181088
        • Univ. of Colorado Denver NICHD CRS
    • Florida
      • Jacksonville, Florida, United States, 32209
        • Univ. of Florida Jacksonville NICHD CRS
    • Illinois
      • Chicago, Illinois, United States, 606143394
        • Chicago Children's CRS
      • Chicago, Illinois, United States, 606371470
        • Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
    • Louisiana
      • New Orleans, Louisiana, United States, 701122699
        • Tulane/LSU Maternal/Child CRS
    • Massachusetts
      • Boston, Massachusetts, United States, 021155724
        • HMS - Children's Hosp. Boston, Div. of Infectious Diseases
    • New York
      • New York, New York, United States, 10032
        • Columbia IMPAACT CRS
      • New York, New York, United States, 10016
        • NYU Med. Ctr., Dept. of Medicine
      • New York, New York, United States, 10032
        • Incarnation Children's Ctr.
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 191044318
        • The Children's Hosp. of Philadelphia IMPAACT CRS
    • Texas
      • Houston, Texas, United States, 77030
        • Texas Children's Hosp. CRS
    • Virginia
      • Richmond, Virginia, United States, 23219
        • VCU Health Systems, Dept. of Peds

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion (Actual)

March 1, 2001

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Actual)

October 29, 2021

Last Update Submitted That Met QC Criteria

October 27, 2021

Last Verified

October 1, 2021

More Information

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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