PROPHYLACTIC INTRAVENOUS IMMUNOGLOBULIN IN HIV-INFECTED CHILDREN WITH CD4+ COUNTS OF 0.20X10(9)/L OR MORE - EFFECT ON VIRAL, OPPORTUNISTIC, AND BACTERIAL-INFECTIONS

Objective.-To evaluate the efficacy of intravenous immunoglobulin (IVIG) for prevention of viral, opportunistic, and minor bacterial infections in children infected with human immunodeficiency virus (HIV). Design.-Randomized, double-blind, placebo-controlled, outpatient clinical trial comparing subjects treated with 400 mg of IVIG per kilogram of body weight every 28 days with those given albumin placebo. Setting.-Twenty-eight clinical centers in mainland United States and Puerto Rico. Patients.-Three hundred seventy-six children infected with human immunodeficiency virus with clinical or immunologic evidence of HIV disease, 313 of whom had entry CD4+ counts of at least 0.20 X 10(9)/L (greater-than-or-equal-to 200/mm3). Main Outcome Measures.-The incidence of laboratory-proven and clinically diagnosed viral, opportunistic, and bacterial infections. Main Results.-Viral infections and minor bacterial infections contributed more frequently to morbidity in children with entry CD4+ counts of at least 0.20 X 10(9)/L (together over five times as frequent) than did serious bacterial infection, the primary outcome measure of the trial. Opportunistic infections occurred at a similar rate as laboratory-proven serious bacterial infections. In this group of children, IVIG was significantly associated with a decrease in the rate of viral infections and minor bacterial infections per 100 patient-years (36.0 vs 54.0 episodes of viral infection per 100 patient-years, IVIG vs placebo, P=.01; and 115.1 vs 159.7 episodes of minor bacterial infection per 100 patient-years, IVIG vs placebo, P=.02), as well as a decrease in the rate of serious bacterial infections per 100 patient-years (26.4 vs 48.2 episodes per 100 patient-years; P=.002). There was no apparent difference in the rate of opportunistic infections between treatment arms. Conclusions.-Beneficial effect of IVIG was seen across multiple infectious outcome measures, with reductions in serious and minor viral and bacterial infections observed in children with entry CD4+ counts of at least 0.20 X 10(9)/L.