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

Completed · Phase 1

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00000849

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

27

Expected to finish

2001-03-01

Last updated by the study team

2021-10-29

Who can join

Age: 3 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• Children will not be eligible for this study if they:
• Have an active opportunistic infection.
• Are pregnant.

Where it is running

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

Full record on ClinicalTrials.gov

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