RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF THE IMMUNE MODULATOR WF10 IN PATIENTS WITH ADVANCED AIDS

A randomized, double-blind trial compared treatment with the immune mo dulator WF10 (ten patients) and placebo (nine patients) administered i n cycles over 3 months among individuals with advanced AIDS. There wer e no notable clinical adverse events; changes in hematologic and chemi stry values were comparable in the two groups. In both groups, median HIV-RNA PCR values remained stable, Immunologic variables showed a con sistent tendency to increase in the WF10 group and to decrease in the control group, with significant differences between groups for median WBC, lymphocyte, CD19, and CD35 values. Ten infections occurred in the control group, four of which were Pneumocystis carinii pneumonia (PCP ), and three in the WF10 group none of which was PCP, Five patients in the control group were hospitalized during the trial for a total of 5 3 days; no patients in the WF10 group were hospitalized. Over a subseq uent 9-months follow-up, six patients from the control group and one f rom the WF10 group died. These results indicate that WF10 administrati on appears safe, may enhance immunologic function, and unlike other ma crophage-activating cytokines does not increase HIV expression in this patient population. Further studies of WF10 in larger patient populat ions are warranted.