Recombinant CD4-IgG2 in human immunodeficiency virus type 1-infected children: phase 1/2 study. The Pediatric AIDS Clinical Trials Group Protocol 351 Study Team.
W T Shearer, R J Israel, S Starr...
https://pubmed.ncbi.nlm.nih.gov/11069253Completed
Phase 1
Age: 2Years - 12Years
All Genders
ID00000876
Phase I/II Trial of CD4-IgG2 in HIV-Infected Children
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-11-03
12
Participants Needed
8
Research Sites
N/A
Total Duration
On this page
Sponsors
N
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Effectiveness of CD4-IgG2 in HIV-Positive Children
Who Can Participate
Age: 2Years - 12Years
All Genders
Eligibility Criteria
You may qualify if you...
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.)
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 8 locations
1
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
Long Beach, California, United States, 90801
Status Unknown
2
Childrens Hosp. LA - Dept. of Ped., Div. of Clinical Immunology & Allergy
Los Angeles, California, United States, 900276016
Status Unknown
3
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
Los Angeles, California, United States, 90090-1752
Status Unknown
4
Children's Hosp. of Orange County
Orange, California, United States, 92868
Status Unknown
5
UCSF Pediatric AIDS CRS
San Francisco, California, United States, 941430105
Status Unknown
6
Children's National Med. Ctr. Washington DC NICHD CRS
Washington D.C., District of Columbia, United States, 20010-2970
Status Unknown
7
Univ. of Florida Jacksonville NICHD CRS
Jacksonville, Florida, United States, 32209
Status Unknown
8
Texas Children's Hosp. CRS
Houston, Texas, United States, 77030
Status Unknown
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
N/A
Model
N/A
Primary Purpose
TREATMENT
Number of Arms
0
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