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

October 27, 2021 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

45

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico
        • San Juan City Hosp. PR NICHD CRS
      • San Juan, Puerto Rico
        • Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • UAB, Dept. of Ped., Div. of Infectious Diseases
    • California
      • Long Beach, California, United States, 90801
        • Long Beach Memorial Med. Ctr., Miller Children's Hosp.
      • Los Angeles, California, United States, 90033
        • 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
      • Oakland, California, United States
        • Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
      • San Francisco, California, United States
        • UCSF Pediatric AIDS CRS
    • Colorado
      • Aurora, Colorado, United States
        • Univ. of Colorado Denver NICHD CRS
    • Connecticut
      • Farmington, Connecticut, United States, 06030
        • Univ. of Connecticut Health Ctr., Dept. of Ped.
    • District of Columbia
      • Washington, District of Columbia, United States, 20060
        • Howard Univ. Washington DC NICHD CRS
      • Washington, District of Columbia, United States
        • Children's National Med. Ctr., ACTU
    • Florida
      • Jacksonville, Florida, United States, 32209
        • Univ. of Florida Jacksonville NICHD CRS
      • Miami, Florida, United States, 33161
        • Univ. of Miami Ped. Perinatal HIV/AIDS CRS
    • Georgia
      • Atlanta, Georgia, United States, 30306
        • Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • 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
    • Massachusetts
      • Boston, Massachusetts, United States
        • HMS - Children's Hosp. Boston, Div. of Infectious Diseases
      • Boston, Massachusetts, United States
        • BMC, Div. of Ped Infectious Diseases
      • Springfield, Massachusetts, United States, 01199
        • Baystate Health, Baystate Med. Ctr.
      • Worcester, Massachusetts, United States
        • WNE Maternal Pediatric Adolescent AIDS CRS
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Children's Hospital of Michigan NICHD CRS
    • New Jersey
      • Paterson, New Jersey, United States
        • St. Joseph's Hosp. & Med. Ctr. of New Jersey
    • New York
      • Albany, New York, United States, 12208
        • Children's Hospital at Albany Medical Center, Dept. of Peds.
      • Brooklyn, New York, United States
        • SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
      • Great Neck, New York, United States, 11021
        • North Shore-Long Island Jewish Health System, Dept. of Peds.
      • New York, New York, United States, 10032
        • Columbia IMPAACT CRS
      • New York, New York, United States, 10037
        • Harlem Hosp. Ctr. NY NICHD CRS
      • New York, New York, United States, 10032
        • Incarnation Children's Ctr.
      • New York, New York, United States
        • NYU Med. Ctr., Dept. of Medicine
      • Rochester, New York, United States
        • Strong Memorial Hospital Rochester NY NICHD CRS
      • Stony Brook, New York, United States
        • SUNY Stony Brook NICHD CRS
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • The Children's Hosp. of Philadelphia IMPAACT CRS
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Med. Univ. of South Carolina, Div. of Ped. Infectious Diseases
    • Tennessee
      • Memphis, Tennessee, United States
        • St. Jude/UTHSC CRS
    • Texas
      • Dallas, Texas, United States, 75235
        • Children's Med. Ctr. Dallas
      • Houston, Texas, United States, 77030
        • Texas Children's Hosp. CRS
    • Washington
      • Seattle, Washington, United States
        • UW School of Medicine - CHRMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

North American Biologicals Inc

Investigators

  • Study Chair: Stiehm ER
  • Study Chair: Wara DW

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion (Actual)

April 1, 1998

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Actual)

November 4, 2021

Last Update Submitted That Met QC Criteria

October 27, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACTG 273
  • 11249 (Registry Identifier: DAIDS ES Registry Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV Infections

Clinical Trials on Anti-HIV Immune Serum Globulin (Human)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bosnia & Herzegovina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe