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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

Since CD4 is the high-affinity receptor for HIV-1, molecules such as CD4-IgG2, which incorporate the gp120 binding region of CD4, have the potential to bind and neutralize all strains of the virus. \[AS PER AMENDMENT 4/25/00: Study results have demonstrated that the product is safe in children, well tolerated, and may have antiviral properties. With these encouraging results in hand, an extra cohort has been added using twice the dose of rCD4-IgG2 as in Cohort I.\]

The study is conducted in two parts. In Part 1 patients receive a single dose of CD4-IgG2 intravenously at 1 of 4 dose levels....

Gender

ALL

Eligibility 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.)