Through a network of 28 collaborating hospitals, a total of 372 immunologically or clinically symptomatic HIV infected children were enrolled in a randomized, double blind, placebo controlled clinical trial which compared the efficacy of intravenous gamma globulin to albumin placebo in reducing the risk of serious bacterial infections and/or deaths in symptomatic HIV infected children. In an interim analysis done under the auspices of the Data Safety Monitoring Board in December of 1990, a significant beneficial effect of IVIG use in reducing the risk of bacterial infection in HIV infected children was noted and the trial, upon the recommendation of the Data Safety Monitoring Board, was therefore stopped. The results of the trial show that the use of intravenous immunoglobulin prolongs the time free from serious laboratory proven bacterial and clinically diagnosed serious infections in symptomatic HIV infected children with entry CD4 lymphocyte counts of 200 per mm-3 or above.
