What is the evidence for using IV immune globulin therapy in pediatric HIV-infected patients for the prevention of bacterial infections?

From Micromedex (Immune globulin monograph, Off-label uses section):
A study by the National Institute of Child Health and Human Development shows that monthly treatment with intravenous immune globulin prolongs the time free from serious bacterial infection in children with symptomatic HIV infection and CD4 counts > 200 cells/mm³ (median time to infection in IVIG vs placebo groups was 681 days vs 283 days); children with CD4 lymphocyte counts less than 200 cells/mm³ do not benefit (NICHD, 1991)(Mofenson & Moye, 1993 FULL-TEXT Fig. 5 shows survival curves for infection free outcome).

In the NICHD multicenter, double-blind, placebo controlled study, 376 children (with clinical evidence of HIV) were randomized to receive 400 mg/kg IVIG every 28 days, or placebo.  Patients continued to receive the prevailing medical standard of care, including PCP prophylaxis and zidovudine.  Results from an open label continuation of this study are published (Mofenson et al, 1994).
There was also a double-blind placebo-controlled trial that randomized 255 HIV+ children (stratified by previous history of serious bacterial infection) to receive AZT plus monthly IVIG therapy or AZT plus placebo.  Spector S. NEJM. 1994;331(18):1181-1187. The study showed a benefit of IVIG for children who were not also receiving trimethoprim-sulfamethoxazole as prophylaxis.
Kaplan-Meier plot that compares time to first serious bacterial infection for children on IVIG versus placebo based on whether the children were also on trimethoprim-sulfamethoxazole.

There has been some research in to the safety of discontinuing IVIG therapy in HIV-infected children who are clinically stable and on antiretroviral therapy, but nothing definitive.


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Clinical Informationist at EUH Branch Library
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