Status:
COMPLETED
Safety and Effectiveness of CD4-IgG2 in HIV-Positive Children
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
HIV Infections
Eligibility:
All Genders
2-12 years
Phase:
PHASE1
Brief 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-I...
Detailed Description
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. \[...
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.)
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
November 1 2006
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00000876
End Date
November 1 2006
Last Update
November 3 2021
Active Locations (8)
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1
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
Long Beach, California, United States, 90801
2
Childrens Hosp. LA - Dept. of Ped., Div. of Clinical Immunology & Allergy
Los Angeles, California, United States, 900276016
3
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
Los Angeles, California, United States, 90090-1752
4
Children's Hosp. of Orange County
Orange, California, United States, 92868