PASSIVE IMMUNOTHERAPY IN AIDS - A DOUBLE-BLIND RANDOMIZED STUDY BASEDON TRANSFUSIONS OF PLASMA RICH IN ANTI-HUMAN-IMMUNODEFICIENCY-VIRUS-IANTIBODIES VS TRANSFUSIONS OF SERONEGATIVE PLASMA

A randomized double-blind controlled trial was conducted to determine the efficacy of passive immunotherapy in the treatment of symptomatic human immunodeficiency virus (HIV) infection, This trial included 86 s ymptomatic patients randomized to receive plasma rich in anti-HIV-1 an tibody or standard seronegative plasma, Each patient in both groups re ceived a 300-ml infusion every 14 days over a 1-year period, and every 28 days thereafter, in addition to zidovudine and other conventional prophylactic treatments, Plasma donors were selected among symptomless seropositive individuals with a CD4 lymphocyte count greater than or equal to 400 x 10(6) cells per liter, a negative p24 antigen assay, an d a high concentration of anti-p24 antibody, The plasmas were heat-ina ctivated before infusion. During the study period (day 28-day 365) sch eduled by the protocol, clinical benefit from passive immunotherapy wa s observed in delaying the appearance of the first AIDS-defining event (P < 0.009) and reducing the cumulative incidence of such events, whi ch was estimated 3-fold higher in the control group compared to the tr eatment group. Seven deaths occurred in the treatment group vs, 11 in the control group (P = 0.27). A total of 47 patients died or exhibited new AIDS-defining events, 18 in the treatment group and 29 in the con trol group (P = 0.009). No clinical benefit was observed after the 1-y ear period with infusions performed every 4 weeks. These results indic ate a favorable effect of passive immunotherapy on the evolution of ad vanced AIDS.