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A Phase I/II Study of Hyperimmune IVIG in Slowing Progression of Disease in HIV-Infected Children

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Anti-HIV Immune Serum Globulin (Human)
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Immunoglobulins, Intravenous, Immunization, Passive

Eligibility Criteria

2 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UAB, Dept. of Ped., Div. of Infectious Diseases
  • Long Beach Memorial Med. Ctr., Miller Children's Hosp.
  • Usc La Nichd Crs
  • Childrens Hosp. LA - Dept. of Ped., Div. of Clinical Immunology & Allergy
  • UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
  • Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
  • UCSF Pediatric AIDS CRS
  • Univ. of Colorado Denver NICHD CRS
  • Univ. of Connecticut Health Ctr., Dept. of Ped.
  • Howard Univ. Washington DC NICHD CRS
  • Children's National Med. Ctr., ACTU
  • Univ. of Florida Jacksonville NICHD CRS
  • Univ. of Miami Ped. Perinatal HIV/AIDS CRS
  • Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases
  • Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
  • Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
  • BMC, Div. of Ped Infectious Diseases
  • HMS - Children's Hosp. Boston, Div. of Infectious Diseases
  • Baystate Health, Baystate Med. Ctr.
  • WNE Maternal Pediatric Adolescent AIDS CRS
  • Children's Hospital of Michigan NICHD CRS
  • St. Joseph's Hosp. & Med. Ctr. of New Jersey
  • Children's Hospital at Albany Medical Center, Dept. of Peds.
  • SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
  • North Shore-Long Island Jewish Health System, Dept. of Peds.
  • Columbia IMPAACT CRS
  • Incarnation Children's Ctr.
  • Harlem Hosp. Ctr. NY NICHD CRS
  • NYU Med. Ctr., Dept. of Medicine
  • Strong Memorial Hospital Rochester NY NICHD CRS
  • SUNY Stony Brook NICHD CRS
  • The Children's Hosp. of Philadelphia IMPAACT CRS
  • Med. Univ. of South Carolina, Div. of Ped. Infectious Diseases
  • St. Jude/UTHSC CRS
  • Children's Med. Ctr. Dallas
  • Texas Children's Hosp. CRS
  • UW School of Medicine - CHRMC
  • San Juan City Hosp. PR NICHD CRS
  • Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 27, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
North American Biologicals Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00000827
Brief Title
A Phase I/II Study of Hyperimmune IVIG in Slowing Progression of Disease in HIV-Infected Children
Official Title
A Phase I/II Study of Hyperimmune IVIG in Slowing Progression of Disease in HIV-Infected Children
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 1998 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
North American Biologicals Inc

4. Oversight

5. Study Description

Brief Summary
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.
Detailed Description
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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Immunoglobulins, Intravenous, Immunization, Passive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
45 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Anti-HIV Immune Serum Globulin (Human)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stiehm ER
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Wara DW
Official's Role
Study Chair
Facility Information:
Facility Name
UAB, Dept. of Ped., Div. of Infectious Diseases
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
City
Long Beach
State/Province
California
ZIP/Postal Code
90801
Country
United States
Facility Name
Usc La Nichd Crs
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Childrens Hosp. LA - Dept. of Ped., Div. of Clinical Immunology & Allergy
City
Los Angeles
State/Province
California
Country
United States
Facility Name
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
City
Oakland
State/Province
California
Country
United States
Facility Name
UCSF Pediatric AIDS CRS
City
San Francisco
State/Province
California
Country
United States
Facility Name
Univ. of Colorado Denver NICHD CRS
City
Aurora
State/Province
Colorado
Country
United States
Facility Name
Univ. of Connecticut Health Ctr., Dept. of Ped.
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
Facility Name
Howard Univ. Washington DC NICHD CRS
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20060
Country
United States
Facility Name
Children's National Med. Ctr., ACTU
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
Univ. of Florida Jacksonville NICHD CRS
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Univ. of Miami Ped. Perinatal HIV/AIDS CRS
City
Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30306
Country
United States
Facility Name
Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
BMC, Div. of Ped Infectious Diseases
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Baystate Health, Baystate Med. Ctr.
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
WNE Maternal Pediatric Adolescent AIDS CRS
City
Worcester
State/Province
Massachusetts
Country
United States
Facility Name
Children's Hospital of Michigan NICHD CRS
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
St. Joseph's Hosp. & Med. Ctr. of New Jersey
City
Paterson
State/Province
New Jersey
Country
United States
Facility Name
Children's Hospital at Albany Medical Center, Dept. of Peds.
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
City
Brooklyn
State/Province
New York
Country
United States
Facility Name
North Shore-Long Island Jewish Health System, Dept. of Peds.
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Columbia IMPAACT CRS
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Incarnation Children's Ctr.
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Harlem Hosp. Ctr. NY NICHD CRS
City
New York
State/Province
New York
ZIP/Postal Code
10037
Country
United States
Facility Name
NYU Med. Ctr., Dept. of Medicine
City
New York
State/Province
New York
Country
United States
Facility Name
Strong Memorial Hospital Rochester NY NICHD CRS
City
Rochester
State/Province
New York
Country
United States
Facility Name
SUNY Stony Brook NICHD CRS
City
Stony Brook
State/Province
New York
Country
United States
Facility Name
The Children's Hosp. of Philadelphia IMPAACT CRS
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Med. Univ. of South Carolina, Div. of Ped. Infectious Diseases
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
St. Jude/UTHSC CRS
City
Memphis
State/Province
Tennessee
Country
United States
Facility Name
Children's Med. Ctr. Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Texas Children's Hosp. CRS
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
UW School of Medicine - CHRMC
City
Seattle
State/Province
Washington
Country
United States
Facility Name
San Juan City Hosp. PR NICHD CRS
City
San Juan
Country
Puerto Rico
Facility Name
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
City
San Juan
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
10669338
Citation
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.
Results Reference
background

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A Phase I/II Study of Hyperimmune IVIG in Slowing Progression of Disease in HIV-Infected Children

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