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

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.

Timeline

Start

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Primary completion

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Completion

1998-04

Publications

• Background Stiehm ER, Fletcher CV, Mofenson LM, Palumbo PE, Kang M, Fenton T, Sapan CV, Meyer WA, Shearer WT, Hawkins E, Fowler MG, Bouquin P, Purdue L, Sloand EM, Nemo GJ, Wara D, Bryson YJ, Starr SE, Petru A, Burchett S. Use of human immunodeficiency virus (HIV) human hyperimmune immunoglobulin in HIV type 1-infected children (Pediatric AIDS clinical trials group protocol 273). J Infect Dis. 2000 Feb;181(2):548-54. doi: 10.1086/315224.

Drugs

Indications