Use of human immunodeficiency virus (HIV) human hyperimmune immunoglobulin in HIV type 1-infected children (Pediatric AIDS clinical trials group protocol 273).
E R Stiehm, C V Fletcher, L M Mofenson...
https://pubmed.ncbi.nlm.nih.gov/10669338Completed
Phase 1
Age: 2Years - 12Years
All Genders
ID00000827
A Phase I/II Study of Hyperimmune IVIG in Slowing Progression of Disease in HIV-Infected Children
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-11-04
45
Participants Needed
39
Research Sites
N/A
Total Duration
On this page
Sponsors
N
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
N
North American Biologicals Inc
Collaborating Sponsor
AI-Summary
What this Trial Is About
To evaluate the safety, tolerance, pharmacokinetics, and antiviral activity of human anti-HIV immune serum globulin ( HIVIG ) at three dosage levels in HIV-infected children. Passive antibody therapy has been used with limited success in treating advanced HIV disease in adults. HIVIG is manufactured from HIV antibody-rich plasma taken from asymptomatic donors. It is hypothesized that HIVIG will decrease the viral burden of moderately advanced HIV-positive children.
CONDITIONS
Official Title
A Phase I/II Study of Hyperimmune IVIG in Slowing Progression of Disease in HIV-Infected Children
Who Can Participate
Age: 2Years - 12Years
All Genders
Eligibility Criteria
You may qualify if you...
Inclusion Criteria
Concurrent Medication:
Required:
- PCP prophylaxis according to CDC guidelines.
Allowed:
- Varicella-zoster immunoglobulin.
- Hepatitis B immunoglobulin.
- Prophylactic therapies not involving immunoglobulin.
Patients must have:
- HIV infection.
- CD4 count > 200 cells/mm3 (ages 2-5 years) or > 100 cells/mm3 (age > 5 years).
- Antiretroviral therapy for at least 6 months, with no change in regimen for at least 3 months prior to study entry.
- Plasma ICD p24 >= 70 pg/ml that is stable or increasing prior to study entry.
- Life expectancy of at least 6 months.
Prior Medication: Required:
- Antiretroviral therapy for at least 6 months, with stable dose for at least 3 months.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
- Severe diarrhea, nephrotic syndrome, or other protein-losing state that requires large doses of IVIG.
- Any other condition requiring dosing with IVIG (e.g., ITP, hypogammaglobulinemia).
- Acute illness with temperature >= 100 F and/or with IV antibiotics.
- Grade 3 or worse clinical toxicities.
- Unable to tolerate IV infusions at a minimum rate of 0.02 ml/kg/min.
- Concomitant participation in an experimental antiretroviral or HIV vaccine trial.
Concurrent Medication:
Excluded:
- IVIG.
- Chemotherapy for an active malignancy.
- MMR or rubella vaccinations.
- Intramuscular immunoglobulin.
Patients with the following prior condition are excluded:
- History of severe reaction to IVIG.
Prior Medication:
Excluded:
- IVIG within the past 60 days.
- Chemotherapy for an active malignancy within the past year.
- MMR or rubella vaccinations within the past 6 months.
- Intramuscular immunoglobulin within the past 60 days.
Ongoing drug or alcohol abuse.
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: 39 locations
1
UAB, Dept. of Ped., Div. of Infectious Diseases
Birmingham, Alabama, United States, 35294
Status Unknown
2
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
Long Beach, California, United States, 90801
Status Unknown
3
Usc La Nichd Crs
Los Angeles, California, United States, 90033
Status Unknown
4
Childrens Hosp. LA - Dept. of Ped., Div. of Clinical Immunology & Allergy
Los Angeles, California, United States
Status Unknown
5
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
Los Angeles, California, United States
Status Unknown
6
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
Oakland, California, United States
Status Unknown
7
UCSF Pediatric AIDS CRS
San Francisco, California, United States
Status Unknown
8
Univ. of Colorado Denver NICHD CRS
Aurora, Colorado, United States
Status Unknown
9
Univ. of Connecticut Health Ctr., Dept. of Ped.
Farmington, Connecticut, United States, 06030
Status Unknown
10
Howard Univ. Washington DC NICHD CRS
Washington D.C., District of Columbia, United States, 20060
Status Unknown
11
Children's National Med. Ctr., ACTU
Washington D.C., District of Columbia, United States
Status Unknown
12
Univ. of Florida Jacksonville NICHD CRS
Jacksonville, Florida, United States, 32209
Status Unknown
13
Univ. of Miami Ped. Perinatal HIV/AIDS CRS
Miami, Florida, United States, 33161
Status Unknown
14
Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases
Atlanta, Georgia, United States, 30306
Status Unknown
15
Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
Baltimore, Maryland, United States, 21201
Status Unknown
16
Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
Baltimore, Maryland, United States
Status Unknown
17
BMC, Div. of Ped Infectious Diseases
Boston, Massachusetts, United States
Status Unknown
18
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
Boston, Massachusetts, United States
Status Unknown
19
Baystate Health, Baystate Med. Ctr.
Springfield, Massachusetts, United States, 01199
Status Unknown
20
WNE Maternal Pediatric Adolescent AIDS CRS
Worcester, Massachusetts, United States
Status Unknown
21
Children's Hospital of Michigan NICHD CRS
Detroit, Michigan, United States, 48201
Status Unknown
22
St. Joseph's Hosp. & Med. Ctr. of New Jersey
Paterson, New Jersey, United States
Status Unknown
23
Children's Hospital at Albany Medical Center, Dept. of Peds.
Albany, New York, United States, 12208
Status Unknown
24
SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
Brooklyn, New York, United States
Status Unknown
25
North Shore-Long Island Jewish Health System, Dept. of Peds.
Great Neck, New York, United States, 11021
Status Unknown
26
Columbia IMPAACT CRS
New York, New York, United States, 10032
Status Unknown
27
Incarnation Children's Ctr.
New York, New York, United States, 10032
Status Unknown
28
Harlem Hosp. Ctr. NY NICHD CRS
New York, New York, United States, 10037
Status Unknown
29
NYU Med. Ctr., Dept. of Medicine
New York, New York, United States
Status Unknown
30
Strong Memorial Hospital Rochester NY NICHD CRS
Rochester, New York, United States
Status Unknown
31
SUNY Stony Brook NICHD CRS
Stony Brook, New York, United States
Status Unknown
32
The Children's Hosp. of Philadelphia IMPAACT CRS
Philadelphia, Pennsylvania, United States, 19104
Status Unknown
33
Med. Univ. of South Carolina, Div. of Ped. Infectious Diseases
Charleston, South Carolina, United States, 29425
Status Unknown
34
St. Jude/UTHSC CRS
Memphis, Tennessee, United States
Status Unknown
35
Children's Med. Ctr. Dallas
Dallas, Texas, United States, 75235
Status Unknown
36
Texas Children's Hosp. CRS
Houston, Texas, United States, 77030
Status Unknown
37
UW School of Medicine - CHRMC
Seattle, Washington, United States
Status Unknown
38
San Juan City Hosp. PR NICHD CRS
San Juan, Puerto Rico
Status Unknown
39
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
San Juan, Puerto Rico
Status Unknown
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
TREATMENT
Number of Arms
0
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