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Effect of Immunomodulator Dzherelo In HIV/TB co-Infected patients receiving anti-tuberculosis therapy under DOTS

Lyudmila G. Nikolaeva1 *, Tatyana V. Maystat1, Volodymyr S. Pylypchuk2, Yuri L. Volyanskii3, Lllla A Masyuk4. Galyna Kutavna5*. 1 Kharkov Regional AIDS Prophylaxis and Prevention Center, Kharkov Medical Academy of Postgraduate Education, 6 Bor'by street, Kharkov 61044, Ukraine; 2Ekomed LLC. Prospect Pravdy 80-A, Kiev 04208, Ukraine: 3I.I. Mechnlkov inslltute of Microbiology and Immunology, Kharkov 61057, Ukraine; 'Jovtnevsky Correctional Colony No.17, State Department of the Penitentiary of Ukraine In Kharkov Region, Kharkov, Ukraine; 5Luhansk Regional AIDS Center and Luhansk State Medical University, Luhansk 91045, Ukraine; "Corresponding author: E-mail:
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-retrovlral therapy naive patients were randomized into two equal groups, to be given anti-tuberculosis therapy (ATT) under DOTS. The arm A, which served as a conlrol, received Isonlazid (H); Rimfapicin (R); Pyrazinamide (Z); Streptomycin (S); and Ethambutol (E), and arm B received 50 drops of Dzherelo twice per day in addition to HR2SE. After 2 months the total CD3 lymphocytes increased from 728 to 921 cells/ul (P=0.025) in Dzherelo recipients, whereas in the control 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-QH+ activated lymphocytes fell in ATT (22.6>20.S; 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 differences were 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 (19.9%>14.5%; P=0.003).The average viral load, as measured by plasma RMA-PCR, decreased in Dzherelo group (2,174>1,558 copies/ml; P=0.002), but increased In ATT group (1,907>2,076; P=0.03). Dzherelo has a favorable effect on the Immune status and viral burden in HIV/TB patients when given as an Immunomodulating adjunct to ATT.

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