title: Effect of oral immunomodulator Dzherelo in TB/HIV co-infected patients receiving anti-tuberculosis therapy under DOTS.
abstract: 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.
authors.affiliation: Kharkov Regional AIDS Prophylaxis and Prevention Center, Kharkov Medical Academy of Postgraduate Education, 6 Bor'by street, Kharkov 61044, Ukraine.
authors.forename: Lyudmila G
authors.initials: LG
authors.lastname: Nikolaeva
authors.forename: Tatyana V
authors.initials: TV
authors.lastname: Maystat
authors.forename: Volodymyr S
authors.initials: VS
authors.lastname: Pylypchuk
authors.forename: Yuri L
authors.initials: YL
authors.lastname: Volyanskii
authors.forename: Lilia A
authors.initials: LA
authors.lastname: Masyuk
authors.forename: Galyna A
authors.initials: GA
authors.lastname: Kutsyna
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000995:Antitubercular Agents / Q000627:therapeutic use*; D001402:B-Lymphocytes / Q000187:drug effects / Q000276:immunology; D018791:CD4 Lymphocyte Count; D015496:CD4-Positive T-Lymphocytes / Q000187:drug effects / Q000276:immunology; D018414:CD8-Positive T-Lymphocytes / Q000187:drug effects / Q000276:immunology; D023801:Directly Observed Therapy; D005260:Female; D015658:HIV Infections / Q000150:complications / Q000188:drug therapy* / Q000276:immunology; D006801:Humans; D007155:Immunologic Factors / Q000008:administration & dosage / Q000276:immunology / Q000627:therapeutic use*; D007694:Killer Cells, Natural / Q000187:drug effects / Q000276:immunology; D008297:Male; D008875:Middle Aged; D008517:Phytotherapy; D010936:Plant Extracts / Q000008:administration & dosage / Q000627:therapeutic use*; D014397:Tuberculosis, Pulmonary / Q000150:complications / Q000188:drug therapy* / Q000276:immunology; D019562:Viral Load
chemical_list: D000995:Antitubercular Agents; D007155:Immunologic Factors; D010936:Plant Extracts