This is a randomized, multicenter parallel dosing phase I/II study evaluating three dose levels of HIVIG given every 4 weeks. Nationwide, 30 children will be randomized to receive HIVIG for 6 months at one of the three dosage levels (200 mg/kg, 400 mg/kg, or 800 mg/kg). Clinical and laboratory evaluations and pharmacokinetic sampling will be performed over 6 months and subjects will then be followed for 3 months after the final HIVIG infusion.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
3M01RR000865-26S1
Application #
6118401
Study Section
Project Start
Project End
Budget Start
1998-10-01
Budget End
1999-09-30
Support Year
26
Fiscal Year
1999
Total Cost
Indirect Cost
Name
University of California Los Angeles
Department
Type
DUNS #
119132785
City
Los Angeles
State
CA
Country
United States
Zip Code
90095
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