Status:

COMPLETED

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

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborating Sponsors:

North American Biologicals Inc

Conditions:

HIV Infections

Eligibility:

All Genders

2-12 years

Phase:

PHASE1

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...

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 hypoth...

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.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

April 1 1998

Estimated Enrollment :

45 Patients enrolled

Trial Details

Trial ID

NCT00000827

End Date

April 1 1998

Last Update

November 4 2021

Active Locations (39)

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Page 1 of 10 (39 locations)

1

UAB, Dept. of Ped., Div. of Infectious Diseases

Birmingham, Alabama, United States, 35294

2

Long Beach Memorial Med. Ctr., Miller Children's Hosp.

Long Beach, California, United States, 90801

3

Usc La Nichd Crs

Los Angeles, California, United States, 90033

4

Childrens Hosp. LA - Dept. of Ped., Div. of Clinical Immunology & Allergy

Los Angeles, California, United States

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