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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.
First Received: November 2, 1999   Last Updated: June 23, 2005   History of Changes
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator: 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

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

Resource links provided by NLM:


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

  Hide Study Locations
Locations
United States, Alabama
Univ of Alabama at Birmingham Schl of Med / Pediatrics
Birmingham, Alabama, United States, 35294
United States, California
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, United States, 941430105
Children's Hosp of Oakland
Oakland, California, United States, 946091809
UCLA Med Ctr / Pediatric
Los Angeles, California, United States, 900951752
Children's Hosp of Los Angeles/UCLA Med Ctr
Los Angeles, California, United States, 900276016
Long Beach Memorial (Pediatric)
Long Beach, California, United States, 90801
Los Angeles County - USC Med Ctr
Los Angeles, California, United States, 90033
United States, Colorado
Children's Hosp of Denver
Denver, Colorado, United States, 802181088
United States, District of Columbia
Howard Univ Hosp
Washington, District of Columbia, United States, 20060
Children's Hosp of Washington DC
Washington, District of Columbia, United States, 200102916
United States, Florida
Univ of Miami (Pediatric)
Miami, Florida, United States, 33161
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, United States, 32209
United States, Georgia
Emory Univ Hosp / Pediatrics
Atlanta, Georgia, United States, 30306
United States, Maryland
Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore, Maryland, United States, 21201
Johns Hopkins Hosp - Pediatric
Baltimore, Maryland, United States, 212874933
United States, Massachusetts
Children's Hosp of Boston
Boston, Massachusetts, United States, 021155724
Boston City Hosp / Pediatrics
Boston, Massachusetts, United States, 02118
Baystate Med Ctr of Springfield
Springfield, Massachusetts, United States, 01199
Univ of Massachusetts Med School
Worcester, Massachusetts, United States, 016550001
United States, Michigan
Children's Hosp of Michigan
Detroit, Michigan, United States, 48201
United States, New Jersey
Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl
Newark, New Jersey, United States, 071072198
Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
Newark, New Jersey, United States, 07103
United States, New York
Univ of Rochester Med Ctr
Rochester, New York, United States, 14642
Harlem Hosp Ctr
New York, New York, United States, 10037
SUNY - Brooklyn
Brooklyn, New York, United States, 11203
North Shore Univ Hosp
Great Neck, New York, United States, 11021
Westchester Hosp
Valhalla, New York, United States, 10595
State Univ of New York at Stony Brook
Stony Brook, New York, United States, 117948111
Columbia Presbyterian Med Ctr
New York, New York, United States, 10032
Children's Hosp at Albany Med Ctr
Albany, New York, United States, 12208
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
New York, New York, United States, 10032
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States, 10016
United States, Ohio
Columbus Children's Hosp
Columbus, Ohio, United States, 432052696
United States, Pennsylvania
Children's Hosp of Philadelphia
Philadelphia, Pennsylvania, United States, 191044318
United States, South Carolina
Med Univ of South Carolina
Charleston, South Carolina, United States, 294253312
United States, Tennessee
Saint Jude Children's Research Hosp of Memphis
Memphis, Tennessee, United States, 381052794
Vanderbilt School of Medicine
Nashville, Tennessee, United States, 37232
United States, Texas
Children's Med Ctr of Dallas
Dallas, Texas, United States, 75235
Texas Children's Hosp / Baylor Univ
Houston, Texas, United States, 77030
United States, Washington
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, United States, 981050371
Puerto Rico
San Juan City Hosp
San Juan, Puerto Rico, 009367344
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, Puerto Rico, 009365067
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     History of Changes
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

Additional relevant MeSH terms:
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Acquired Immunodeficiency Syndrome
Infection
Pharmacologic Actions
Immunologic Deficiency Syndromes
Immune Sera
Virus Diseases
Immunoglobulins, Intravenous
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on November 27, 2009