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 s tudies are not available. Objective: To determine the efficacy of intr avenous (IV) immune globulin therapy in preventing infections and redu cing days with fever, as well as the duration and frequency of hospita lization for human immunodeficiency virus-infected adults, in a prospe ctive, randomized outpatient clinical trial. Methods: Adult patients w ho met Centers for Disease Control and Prevention criteria B and C wer e randomized to be treated with (n=70) or without (n=57) IV immune glo bulin. Patients who were assigned to treatment with IV immune globulin received 400 and 200 mg/kg of this drug initially and every 21 days t hereafter, respectively. Primary end points were the occurrence of lab oratory-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 whic h the patients who met Centers for Disease Control and Prevention crit eria B and C were free from serious infection (P<.001). Twelve (17%) o f the patients who received IV immune globulin had infection-related d eaths compared with 20 (35%) of the control patients; however, this wa s not statistically significant (P=.06). Furthermore, immune globulin treatment was associated with an overall reduction in the number and d uration of hospitalizations for short-term care (P=.002), days with fe ver (P<.001), and frequency of diarrhea (P<.001). Because of these res ults, the study was stopped by the local ethical board. Conclusion: Pr ophylactic IV immune globulin treatment in human immunodeficiency viru s-infected adults decreases the frequency of serious infections and is associated with a reduction of hospitalization for shortterm care.