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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) North American Biologicals Inc |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000827 |
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 |
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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 |
Estimated Enrollment: | 45 |
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.
Ages Eligible for Study: | 2 Years to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Required:
Allowed:
Patients must have:
Prior Medication: Required:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following prior condition are excluded:
Prior Medication:
Excluded:
Ongoing drug or alcohol abuse.
Study Chair: | Stiehm ER | |
Study Chair: | Wara DW |
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 |
Acquired Immunodeficiency Syndrome AIDS-Related Complex Immunoglobulins, Intravenous Immunization, Passive |
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 |
RNA Virus Infections Slow Virus Diseases Immunologic Factors Immune System Diseases |
Physiological Effects of Drugs Lentivirus Infections Infection Pharmacologic Actions |