Title: Comparative effect of an immunomodulator Immunoxel (DzhereloT™) when used alone or in combination with antiretroviral therapy in drug-naive HIV-infected individuals

Authors: Revaz Chkhetiany, Vladimir Pylipchuk, Olga Argzanova, Nathalia Prihoda, Ludmila Vihrova, Elena Zagaynova, Galina Kutsyna

Addresses: Regional AIDS Center, Luhansk, Ukraine. ' EKOMED Company Ltd., Kiev, Ukraine. ' Tuberculosis Hospital, Lisichansk, Ukraine. ' Tuberculosis Hospital, Lisichansk, Ukraine. ' Regional Hospital, Lisichansk, Ukraine. ' Luhansk Regional AIDS Center, 50-years of Defense of Luhansk Street, Luhansk 91045, Ukraine. ' Luhansk Regional AIDS Center, 50-years of Defense of Luhansk Street, Luhansk 91045, Ukraine

Abstract: Immunomodulating agent Immunoxel (Dzherelo) has been evaluated in 70 HIV-positive individuals divided into three arms: first, control arm, received standard antiretroviral therapy zidovudine/lamivudine/efavirenz (AZT7/3TC/EFV); second-AZT/3TC/EFV+Immunoxel and third, Immunoxel alone, given orally, twice daily. At 32 weeks of follow-up CD4 cell counts increased in all arms, reaching + 102, +190 and +175 cells/mm³, respectively. The proportion of patients who experienced adverse events attributable to study medication was 65%, 24% and 5%. Immunoxel attenuated hepatic toxicity in patients receiving ART as determined by liver function test. Baseline values for ALT aminotransferase were 36, 62 and 72 U/L, which at study conclusion have risen to 78 U/L in arm A, but declined to 38 and 31 U/L in arms B and C. Immunoxel also reversed AIDS-associated wasting. The average weight gain was 1.4, 6.9 and 5.1kg. The results indicate that Immunoxel is safe and exerts beneficial effect in AIDS patients.

Keywords: cachexia; hepatotoxicity; immune tolerance; CD4 cell counts; immunotherapy; phytotherapy; transaminase; antiretroviral therapy; HIV infection; immunomodulating agents; AIDS.

DOI: 10.1504/IJBT.2007.014248

International Journal of Biotechnology, 2007 Vol.9 No.3/4, pp.267 - 276

Published online: 27 Jun 2007 *

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