Interleukin-2 Plus Anti-HIV Therapy in HIV-Infected Children With Weakened Immune Systems

Completed · Phase 1

Conditions studied: HIV Infections

In brief

The purpose of this study is to determine the safety of a drug called interleukin-2 (IL-2) given with anti-HIV therapy in children with HIV infection. This study will also determine the best dose of IL-2 to give children. IL-2 is an important substance produced by the body's white blood cells that helps the body fight infection. People with HIV infection do not produce enough IL-2. It is hoped that IL-2 treatment will help boost the immune system in people with HIV infection. It has not been studied very much in children and doctors need to know what doses are safe to give.

Key facts

Study ID

NCT00006066

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

92

Expected to finish

2006-06-01

Last updated by the study team

2021-11-01

Who can join

Age: 2 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A child may be eligible for this trial if he/she:
• Is HIV-positive.
• Is 2 to 18 years old (consent of parent or guardian required if under 18).
• Has received 12 or more weeks of anti-HIV drug therapy, consisting of at least 3 drugs. This combination may include a nucleoside reverse transcriptase inhibitor (NRTI), a nonnucleoside reverse transcriptase inhibitor, or a protease inhibitor, or 3 NRTIs. Combinations of NRTIs may not include abacavir (ABC). Patients may have taken ABC if it was not in combination with 2 other NRTIs. (This reflects a change in the requirement for anti-HIV therapy.)
• Has a plasma HIV RNA level of less than 10,000 copies/ml.
• Has evidence of a weakened immune system (based on CD4 cell counts and absolute CD4 percentage less than 25 percent). (This reflects a change in how a weakened immune system is defined.)
• Has a parent or guardian who is willing to comply with study requirements.
• Has symptoms of HIV infection.

You may not qualify if…

• A child will not be eligible for this study if he/she:
• Has an active opportunistic (AIDS-related) infection.
• Is pregnant.
• Is taking certain medications, such as steroids or other drugs that affect the immune system, within 6 weeks prior to study entry.
• Is taking ABC.
• Is taking certain antibodies.
• (Exclusion criteria reflect changes.)

Where it is running

• Long Beach Memorial Med. Ctr., Miller Children's Hosp. — Long Beach, California, United States
• Usc La Nichd Crs — Los Angeles, California, United States
• UCSD Maternal, Child, and Adolescent HIV CRS — San Diego, California, United States
• UCSF Pediatric AIDS CRS — San Francisco, California, United States
• Children's National Med. Ctr. Washington DC NICHD CRS — Washington D.C., District of Columbia, United States
• Children's National Med. Ctr., ACTU — Washington D.C., District of Columbia, United States
• Univ. of Miami Ped. Perinatal HIV/AIDS CRS — Miami, Florida, United States
• USF - Tampa NICHD CRS — Tampa, Florida, 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 Ny Nichd Crs — New York, New York, United States
• Columbia IMPAACT CRS — New York, New York, United States
• SUNY Upstate Med. Univ., Dept. of Peds. — Syracuse, New York, United States
• Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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