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A Controlled Trial of Intravenous Immune Globulin for the Prevention of Serious Infections in Adults With Advanced Human Immunodeficiency Virus Infection

Michael G. Kiehl, MD; Reinhard Stoll, MD; Martin Broder; Carsten Mueller, MD; Ernst-Ch. Foerster, MD, PhD; Wolfram Domschke, MD
Arch Intern Med. 1996;156(22):2545-2550. doi:10.1001/archinte.1996.00440210053005.
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Background:  Studies on human immunodeficiency virus—infected children suggest that high-dose immune globulin therapy might be beneficial in reducing the episodes of recurrent infections. In adults, comparable studies are not available.

Objective:  To determine the efficacy of intravenous (IV) immune globulin therapy in preventing infections and reducing days with fever, as well as the duration and frequency of hospitalization for human immunodeficiency virus—infected adults, in a prospective, randomized outpatient clinical trial.

Methods:  Adult patients who met Centers for Disease Control and Prevention criteria B and C were randomized to be treated with (n=70) or without (n=57) IV immune globulin. Patients who were assigned to treatment with IV immune globulin received 400 and 200 mg/kg of this drug initially and every 21 days thereafter, respectively. Primary end points were the occurrence of laboratory-proved or clinically diagnosed infections and death caused by infection.

Results:  In comparison with patients in the control group, IV immune globulin treatment significantly increased the time for which the patients who met Centers for Disease Control and Prevention criteria B and C were free from serious infection (P<.001). Twelve (17%) of the patients who received IV immune globulin had infection-related deaths compared with 20 (35%) of the control patients; however, this was not statistically significant (P=.06). Furthermore, immune globulin treatment was associated with an overall reduction in the number and duration of hospitalizations for short-term care (P=.002), days with fever (P<.001), and frequency of diarrhea (P<.001). Because of these results, the study was stopped by the local ethical board.

Conclusion:  Prophylactic IV immune globulin treatment in human immunodeficiency virus—infected adults decreases the frequency of serious infections and is associated with a reduction of hospitalization for shortterm care.Arch Intern Med. 1996;156:2545-2550


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