Safety and Effectiveness of CD4-IgG2 in HIV-Positive Children

• Status: Completed
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: All

Summary

CD4-IgG2 is a special man-made protein that was built to block the entrance of HIV into CD4 cells (cells of the immune system that fight infection). The purpose of this study is to see if giving CD4-IgG2 to HIV-infected children is safe and effective.

HIV attaches to CD4 cells and enters them. Inside, HIV makes copies of itself that will help the virus invade the body. CD4 cells are killed or disabled during this process of HIV replication. Decreases in CD4 cells lead to a weakened immune system. When CD4 cell counts become very low, the body is unable to defend itself, and HIV infection develops into AIDS. The protein used in this study, CD4-IgG2, may be able to attach to HIV and inactivate it so that it cannot enter CD4 cells. This is an early study to examine CD4-IgG2 as a possible treatment for HIV in children.

• 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: CD4 Immunoadhesins; Immunoglobulin G

Criteria

Inclusion Criteria

Children may be eligible for this study if they:

• Are HIV-positive.

• Are 2-12 years old and have consent of parent or legal guardian.

• Have HIV levels of 10,000 copies/ml or more on at least 2 occasions and 30 days apart (Part 2 only).

• Have been on stable, unchanged anti-HIV therapy for 3 months before study entry.

Exclusion Criteria

Children will not be eligible for this study if they:

• Have an active opportunistic (HIV-related) infection.

• Are pregnant.

• Are taking certain medications.

• Have received any vaccinations within 30 days prior to study entry.

• Have a heart problem that would affect their ability to take part in the study. (This study has been changed. The original version didn't mention heart problems.)