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

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/mm, 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.