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| Descriptive Information Fields | |||||||||
| Brief Title † | A Phase I/II Study of Hyperimmune IVIG in Slowing Progression of Disease in HIV-Infected Children | ||||||||
| Official Title † | A Phase I/II Study of Hyperimmune IVIG in Slowing Progression of Disease in HIV-Infected Children | ||||||||
| 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 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. |
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| 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. |
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| Study Phase | Phase I | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Pharmacokinetics Study | ||||||||
| Primary Outcome Measure † | |||||||||
| Secondary Outcome Measure † | |||||||||
| Condition † | HIV Infections | ||||||||
| Intervention † | Drug: Anti-HIV Immune Serum Globulin (Human) | ||||||||
| MEDLINE PMIDs | 10669338 | ||||||||
| Links | |||||||||
| Recruitment Information Fields | |||||||||
| Recruitment Status † | Completed | ||||||||
| Enrollment † | 45 | ||||||||
| Start Date † | |||||||||
| Completion Date | |||||||||
| Eligibility Criteria † | 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. |
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| Gender | Both | ||||||||
| Ages | 2 Years to 12 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† | |||||||||
| Location Countries † | United States, Puerto Rico | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00000827 | ||||||||
| Organization ID | ACTG 273 | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||
| Collaborators †† | North American Biologicals Inc | ||||||||
| Investigators † |
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| Information Provided By | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||
| Verification Date | January 2003 | ||||||||
| First Received Date † | November 2, 1999 | ||||||||
| Last Updated Date | June 23, 2005 | ||||||||