Effect of oral immunomodulator Dzherelo in TB/HIV co-infected patients receiving anti-tuberculosis therapy under DOTS.

Open-label, phase II clinical trial was conducted in 40 HIV/TB dually infected patients to evaluate the effect of oral immunomodulator Dzherelo on immune and viral parameters. The anti-retroviral therapy naïve patients were randomized into two equal groups to be given anti-tuberculosis therapy (ATT) under DOTS. The arm A, which served as a control, received Isoniazid (H); Rimfapicin (R); Pyrazinamide (Z); Streptomycin (S); and Ethambutol (E), and arm B received 50 drops of Dzherelo twice per day in addition to the daily dose of HRZSE. After 2months the total CD3+ lymphocytes increased from 728 to 921cells/microl (P=0.025) in Dzherelo recipients, whereas in the control group they decreased from 651 to 585 cells (P=0.25). The population of CD4 T-cells expanded in Dzherelo arm (174 to 283; P=0.00003) but declined in ATT group (182 to 174; P=0.34). The CD8 cells fluctuated slightly upward in both groups: 159>180 (P=0.17) and 159>183 (P=0.13). The ratio between CD4/CD8 cells deteriorated in arm A (1.213>0.943; P=0.002) but improved in arm B (1.244>1.536; P=0.007). The percent of CD3+HLA-DR+ activated lymphocytes had fallen in ATT group (22.6>20.5; P=0.004), but rose in Dzherelo recipients (21.5>30.5; P=0.0001). The changes in CD20+ B lymphocytes were insignificant in both arms (28.4%>28.6%; P=0.4) and (27.2%>26.7%; P=0.38). No difference was seen in the amount of CD3-CD16+CD56+ natural killer (NK) cells in arm A (21.3%>22.6%; P=0.1), while in Dzherelo recipients they declined significantly (19.9%>14.5%; P=0.0026). The viral load, measured by plasma RNA-PCR, decreased in Dzherelo group (2174>1558; P=0.002), but increased in ATT group (1907>2076 copies/ml; P=0.03). Dzherelo has a favorable effect on the immune status and viral burden in HIV/TB patients when given as the immunomodulating adjunct to ATT.