CROSSOVER OF PLACEBO PATIENTS TO INTRAVENOUS IMMUNOGLOBULIN CONFIRMS EFFICACY FOR PROPHYLAXIS OF BACTERIAL-INFECTIONS AND REDUCTION OF HOSPITALIZATIONS IN HUMAN IMMUNODEFICIENCY VIRUS-INFECTED CHILDREN

After completion of a placebo-controlled trial of intravenous immunogl obulin (IVIG) infection prophylaxis, patients were offered open label IVIG and optional participation in a follow-up study. The purpose of t he follow-up study was to evaluate the IVIG effect in original placebo recipients and longevity of IVIG benefit in original IVIG recipients. Of 212 human immunodeficiency virus-infected children on study at tri al closure, 148 (67 of 98 (68%) placebo and 81 of 114 (71%) IVIG patie nts) received open label IVIG for a mean of 16 months. When open label IVIG was begun, 45% were receiving trimethoprim-sulfamethoxazole prop hylaxis for Pneumocystis carinii pneumonia (43% of placebo and 47% of IVIG patients) and 54% were receiving zidovudine (55% of placebo and 5 3% of IVIG patients). In patients who received placebo during the orig inal study, the rate of serious bacterial infections was significantly lower after change to open label IVIG (estimated 15.8 fewer episodes/ 100 patient years; 95% confidence interval, 3.2 to 28.5; P = 0.014). S imilar findings were observed for minor bacterial infections (estimate d 61.2 fewer/100 patient years; 95% confidence interval, 29.2 to 93.3; P < 0.001) and hospitalizations (estimated 43.7 fewer/100 patient yea rs; 95% confidence interval, 27.7 to 59.6; P < 0.001). Decreases were observed whether or not trimethoprim-sulfamethoxazole prophylaxis was being given at the time open label IVIG was begun. In patients who rec eived IVIG during the original study, no significant difference was se en in infections or hospitalizations after change to open label IVIG. These results confirm IVIG effectiveness for reduction of bacterial in fections and hospitalizations in human immunodeficiency virus-infected children and indicate that benefit is maintained for at least 3 years . In this patient cohort decrease in infections and hospitalizations w ith IVIG was independent of trimethoprim-sulfamethoxazole P. carinii p neumonia prophylaxis.