THE USE OF INTRAVENOUS IMMUNOGLOBULINS IN SYMPTOMATIC HIV-INFECTION -RESULTS OF A RANDOMIZED STUDY

To study the efficacy of intravenous immunoglobulin in symptomatic inf ection with human immunodeficiency virus (HIV) we enrolled 35 patients with CD4 lymphocyte counts below 300/mu l in a randomized three-arm s tudy. In addition to standard HIV treatment (e.g., zidovudine, aerosol ized pentamidine), 13 patients were treated with 7.5 g and 11 with 40 g of a 7 S intravenous IgG preparation every 4 weeks over a period of 1 year. A control group of 11 patients remained on standard treatment. Clinical and laboratory parameters, including lymphocyte proliferatio n and in vitro immunoglobulin synthesis were evaluated prior to intrav enous IgG administration. HIV-specific immunological abnormalities suc h as increased B-cell activation and B-cell immaturity were observed i n all three study groups at the beginning of the study. Mitogen-induce d lymphocyte proliferation was diminished. These disturbances were not influenced by intravenous IgG treatment. Further laboratory data and the course of the HIV infection (fever, antibiotic treatment, hospital ization, Candida and herpes simplex or cytomegalovirus infection) rema ined unchanged. Thus, our data with an observation period of 12 months do not support the use of intravenous IgG treatment in adult symptoma tic HIV-infected patients with CD4 counts lower than 300/mu l.