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Effects of a novel immunomodulator in HIV infected individuals


   K. Galina, Z. Etena, Z. Iryna
  Medical Institute Kiev, Luhansk AIDS-Center, Department of Infectious Disease of Krasnodon, Sverdlovsk, Kremennoye, Severodonetsk, Rubezhnoye, Lisichansk, Ukraine.
   The Ukraine shares with other resource limited European countries the great challenge of HIV infection. Access to combination antiretroviral therapy is unobtainable for the majority of patients and novel, less expensive options are urgently needed. To this end we have been investigating a naturally derived agent Dzerelo, which may contain immunoenhancing qualities beneficial to HIV infected pntients.
    150 HIV infected patients received Dzerelo(50 drops — twice daily, thirty minutes prior to a meal) for 12 weeks. The control group of 120 patients riceived no therapy. Patients were followed for an average of 12 months. Patients were not receiving other ARV therapy and had not in the past. Conventional HIV RNA and CD-4 cell counts could not be monitored due to financial limitations, therefore a decline in the total lymphocyte counts (TLC) and hemoglobin (Hgb) concentration in the blood were used to monitor the patient's disease status (Johns Hopkins Bloomberg School of Public Health 1984-1991)Clinical progression to HIV/AIDS was also assessed.
   Patients were aged 18 to -42. Baseline demographic, immunological and anthropometric characteristics were balance between the two groups. 20/150 therapy and 20/ 120 control patients had AIDS at baseline. No differences were detected between the groups during the first 4 weeks in total lymphocyte or total leukocyte counts. After 8 weeks, significant changes in TLC were seen: +63. +101, +275, +453. +624. +710 and -24, -15, -31,- 40, -64, -119 cclls/mm3 from baseline level by 8, 12, 16, 20, 24, 48 weeks for therapy and control groups respectively. Increases in TLC in the therapy group appeared dependent on baseline levels. In treated patients with TLC <1300 cells/mm3 at baseline, only 49,3 % returned to normal levels. Those with TLC >1300 cells/mm3 at baseline 84.3 % returned to normal levels during continued follow up. In the control group TLC declined by a mean 4,2% during the 24-week study period, and 7,8% during a 48-week follow up. In the both the therapy and control groups were patients with clinical arid laboratory parameters of anemia. In the therapy group 34 patients had a mean baseline Hgb level of 8.9 g/dl. (P=0.05), and in the control group 28 patients had a Hgb level of 9.3 g/dl (P=0.03). From week 8-24 Hgb increased in the therapy group to a mean of 11.7 g/dl (P=0.04). Compared to a decrease to 9.0 g/ dl  in the control group. (P=0.03). New events of HIV disease progression to AIDS occurred in 1 patient (1.5%.) in the therapy group and 8 patients (8%) in the control group, during the 48-week follow up period.
     Our results suggest a beneficial effect of Dzerelo as a potential immunoen-hancer in HIV infected patients. Improvements in both laboratory markers (TLC, Hgb) and clinical progression were seen. This compound merits further study as an inexpensive agent for HIV infected individuals in resource poor settings. It will be perspective use combination ARV and this imunomodulate therapy for improve immunological effects.



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