A controlled trial of intravenous immune globulin for the prevention of serious infections in adults with advanced human immunodeficiency virus infection

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.