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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.
Sponsors and Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
North American Biologicals Inc
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000827
  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 I

MedlinePlus related topics: AIDS
Drug Information available for: Immunoglobulins Globulin, Immune
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Pharmacokinetics Study
Official Title: A Phase I/II Study of Hyperimmune IVIG in Slowing Progression of Disease in HIV-Infected Children

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

Estimated Enrollment: 45
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

Ages Eligible for Study:   2 Years to 12 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000827

  Show 42 Study Locations
Sponsors and Collaborators
North American Biologicals Inc
Investigators
Study Chair: Stiehm ER
Study Chair: Wara DW
  More Information

Publications:
Study ID Numbers: ACTG 273
Study First Received: November 2, 1999
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00000827  
Health Authority: United States: Federal Government

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

Study placed in the following topic categories:
Sexually Transmitted Diseases, Viral
Acquired Immunodeficiency Syndrome
Disease Progression
AIDS-Related Complex
Immunologic Deficiency Syndromes
Immune Sera
Virus Diseases
Antibodies
HIV Infections
Immunoglobulins, Intravenous
Sexually Transmitted Diseases
Retroviridae Infections
Immunoglobulins

Additional relevant MeSH terms:
RNA Virus Infections
Slow Virus Diseases
Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Lentivirus Infections
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009