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Influence of novel immunomodulator to the prevalence of new events opportunistic infections in untreated HIV- infected individuals.

G. Kutsvna1, R. Chehitiany1, I. Bascacov1, E. Zagaydanova1, I. Zaharova1 Luhansk AIDS-center, Department of Infectious Disease of Krasnodon, Sverdlovsk, Severodonetsk, - Lisichansk, Rubezhnoye, Ukraine.

Access to combination antiretroviral therapy isunobtainable for the majority of patients in Ukraine. In this situation opportunistic infections (O.I.) are the main factor of mortality patients. We studied the influence of immunomodulate agent of Dzerelo to the frequencies of new events 0.I. and markers of HIV disease progression in untreated HIV infected patients. 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 received no therapy. Patients were followed for an average of 12 months, Conventional HIV RNA and CD4 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). Frequencies of new events O.I and clinical progression to HIV/AIDS was observed. 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. After 8 weeks, significant changes in TLC were seen: +63,+ 101,+ 275,+453,+ 624, + 710 and -24,-15,-31,-40,-64,-119 cells/mm3 from baseline level by 8,12,16, 20, 24, 48 weeks for therapy and control groups respectively. In the both the therapy and control groups were patients with clinical and 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 11.7g/dl (P= 0.04).Compared to a decrease to 9.0 g/dl in the control group (P = 0.03). During 48 week follow up period new events O.I were observed in 14(9,3%) and 29(31,2%) patients for therapy and control groups respectively . Among them were oral or esophageal candidacies 3(2%) and 9 (7,2%) , herpes zoster 2(1,3%) and 8(6,4%), bacterial pneumonia 5 (3,3%) and 7(5,6%), tuberculosis 1(0,7%) and 4 (3,2%), TORCH- Infection 3(2%) and 8(6,4%), herpes zoster meningitis any case and 3(2,4%) patients in the therapy and control groups respectively. New events of HIV disease progression to AIDS occurred in 1(1.5%)patient in the therapy group and 8(8 %) patients in the control group for study period. Our results suggest a beneficial effect of Dzerelo as a potential immunoenhancer in HIV infected patients. Improvements in both laboratory markers (TLC, Hgb), decrease the frequencies of O.I. and clinical progression were seen. This compound merits further study combination this immunomodulate agent with ARV for improve immunological effect and decrease the risk of develop O.I.

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