Azimexon, a 2-cyan-aziridinyl immune modulator, was given at a dose of 250 mg/m2/day for 10 days IV to 12 patients with AIDS and 16 with AIDS related complex (ARC). A decrease in total number of AIDS related symptoms from 43 to 24 and in mean number from 2.6 to 1.5 was observed among ARC patients (p<.01). The most commonly improved symptoms were diarrhea, fatigue, and weight loss with the least frequently improved being lymphadenopathy. The following improvements in immune parameters were observed among ARC patients. DTH to recall antigens improved with an increase in number of positive tests from 35 to 47 and in mean number of positive skin tests from 2.2 on day 0 to 2.9 on day 14 (P<.05). The geometric mean of the absolute lymphocyte count was 1.395 × 103/μl on day 0 with a significant increase of 18.0 percent on day 5 (P<.01) and a 7.7 percent increase on day 21. The geometric mean of the 0KT4+ cells on day 0 was 0.250 × 103/μl with a 33.3 percent increase on day 5 (P<.07) and a 14.1 percent increase on day 21. T4/T8 ratio increased by 32.7 percent on day 5 (P<.05) and by 19.4 percent on day 21 from an initial geometric mean of 0.339 × 103/μl on day 0. The geometric mean of GVH responses increased by 18.2 percent on day 5 (P<.05) and by 24.0 percent on day 21 (P<.07) from an initial value of 41.04 mm3. No symptomatic or immunologic improvements were observed among AIDS patients, but rather a significant decrease in mitogenic responses. PHA responses decreased by 70.3 percent on day 5 (P<.05) and 42.2 percent on day 21 from an initial geometric mean of 4.02 × 103 cpm/103. Con-A responses decreased by 75.1 percent on day 5 (P<.05) and increased by 20.3 percent on day 21 from an initial value of 1.14 × 103/105 cells. Pretreatment number of absolute 0KT4+ cells was the most significant prognostic survival variable. Thus, 8/9 patients with <0.10 × 103 0KT4+ blood cell/μl subsequently died as compared to only 1/17 with ≥0.10 × 103 0KT4+ cells (p<.001). The only toxic effect of this treatment was mild hemolysis which disappeared upon cessation of treatment. Azimexon may ameliorate symptomatology and immune parameters in ARC but not in AIDS patients. A larger controlled trial will have to be conducted to verify these observations. Emphasis in studies of this and other potential immunorestoratives should be placed on ARC rather than AIDS patients.
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