A Phase I/II Study of Hyperimmune IVIG in Slowing Progression of Disease in HIV-Infected Children
NCT ID: NCT00000827
Last Updated: 2021-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
45 participants
INTERVENTIONAL
1998-04-30
Brief Summary
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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.
Detailed Description
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Children are randomized to receive HIVIG every 4 weeks for 6 months at one of three dose levels, then are followed for 3 months after the final infusion.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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Anti-HIV Immune Serum Globulin (Human)
Eligibility Criteria
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Inclusion Criteria
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
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.
2 Years
12 Years
ALL
No
Sponsors
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North American Biologicals Inc
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Stiehm ER
Role: STUDY_CHAIR
Wara DW
Role: STUDY_CHAIR
Locations
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UAB, Dept. of Ped., Div. of Infectious Diseases
Birmingham, Alabama, United States
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
Long Beach, California, United States
Usc La Nichd Crs
Los Angeles, California, United States
Childrens Hosp. LA - Dept. of Ped., Div. of Clinical Immunology & Allergy
Los Angeles, California, United States
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
Los Angeles, California, United States
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
Oakland, California, United States
UCSF Pediatric AIDS CRS
San Francisco, California, United States
Univ. of Colorado Denver NICHD CRS
Aurora, Colorado, United States
Univ. of Connecticut Health Ctr., Dept. of Ped.
Farmington, Connecticut, United States
Howard Univ. Washington DC NICHD CRS
Washington D.C., District of Columbia, United States
Children's National Med. Ctr., ACTU
Washington D.C., District of Columbia, United States
Univ. of Florida Jacksonville NICHD CRS
Jacksonville, Florida, United States
Univ. of Miami Ped. Perinatal HIV/AIDS CRS
Miami, Florida, United States
Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases
Atlanta, Georgia, United States
Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
Baltimore, Maryland, United States
Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
Baltimore, Maryland, United States
BMC, Div. of Ped Infectious Diseases
Boston, Massachusetts, United States
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
Boston, Massachusetts, United States
Baystate Health, Baystate Med. Ctr.
Springfield, Massachusetts, United States
WNE Maternal Pediatric Adolescent AIDS CRS
Worcester, Massachusetts, United States
Children's Hospital of Michigan NICHD CRS
Detroit, Michigan, United States
St. Joseph's Hosp. & Med. Ctr. of New Jersey
Paterson, New Jersey, United States
Children's Hospital at Albany Medical Center, Dept. of Peds.
Albany, New York, United States
SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
Brooklyn, New York, United States
North Shore-Long Island Jewish Health System, Dept. of Peds.
Great Neck, New York, United States
Columbia IMPAACT CRS
New York, New York, United States
Incarnation Children's Ctr.
New York, New York, United States
Harlem Hosp. Ctr. NY NICHD CRS
New York, New York, United States
NYU Med. Ctr., Dept. of Medicine
New York, New York, United States
Strong Memorial Hospital Rochester NY NICHD CRS
Rochester, New York, United States
SUNY Stony Brook NICHD CRS
Stony Brook, New York, United States
The Children's Hosp. of Philadelphia IMPAACT CRS
Philadelphia, Pennsylvania, United States
Med. Univ. of South Carolina, Div. of Ped. Infectious Diseases
Charleston, South Carolina, United States
St. Jude/UTHSC CRS
Memphis, Tennessee, United States
Children's Med. Ctr. Dallas
Dallas, Texas, United States
Texas Children's Hosp. CRS
Houston, Texas, United States
UW School of Medicine - CHRMC
Seattle, Washington, United States
San Juan City Hosp. PR NICHD CRS
San Juan, , Puerto Rico
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
San Juan, , Puerto Rico
Countries
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References
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Stiehm ER, Fletcher CV, Mofenson LM, Palumbo PE, Kang M, Fenton T, Sapan CV, Meyer WA, Shearer WT, Hawkins E, Fowler MG, Bouquin P, Purdue L, Sloand EM, Nemo GJ, Wara D, Bryson YJ, Starr SE, Petru A, Burchett S. Use of human immunodeficiency virus (HIV) human hyperimmune immunoglobulin in HIV type 1-infected children (Pediatric AIDS clinical trials group protocol 273). J Infect Dis. 2000 Feb;181(2):548-54. doi: 10.1086/315224.
Other Identifiers
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11249
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG 273
Identifier Type: -
Identifier Source: org_study_id