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

• Status: Completed
• Trial end date: 2006-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Aldesleukin; Interleukin-2

Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.)