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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000827
First Posted: August 31, 2001
Last Update Posted: March 17, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
North American Biologicals Inc
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
  Purpose

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.


Condition Intervention Phase
HIV Infections Drug: Anti-HIV Immune Serum Globulin (Human) Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase I/II Study of Hyperimmune IVIG in Slowing Progression of Disease in HIV-Infected Children

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 45
Study Completion Date: April 1998
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000827


  Show 39 Study Locations
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
North American Biologicals Inc
Investigators
Study Chair: Stiehm ER
Study Chair: Wara DW
  More Information

Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000827     History of Changes
Other Study ID Numbers: ACTG 273
11249 ( Registry Identifier: DAIDS ES Registry Number )
First Submitted: November 2, 1999
First Posted: August 31, 2001
Last Update Posted: March 17, 2014
Last Verified: May 2012

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Immunoglobulins, Intravenous
Immunization, Passive

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Immune Sera
Immunologic Factors
Physiological Effects of Drugs