A phase I trial of andrographolide in HIV positive patients and normal volunteers

A phase I dose-escalating clinical trial of andrographolide from Andrograph is paniculata was conducted in 13 HIV positive patients and five HIV uninfe cted, healthy volunteers. The objectives were primarily to assess safety an d tolerability and secondarily to assess effects on plasma virion HIV-1 RNA levels and CD4(+) lymphocyte levels. No subjects used antiretroviral medic ations during the trial, Those with liver or renal abnormalities were exclu ded. The planned regimen was 5 mg/kg bodyweight for 3 weeks, escalating to 10 mg/kg bodyweight for 3 weeks, and to 20 mg/kg bodyweight for a final 3 w eeks, The trial was interrupted at 6 weeks due to adverse events including an anaphylactic reaction in one patient. All adverse events had resolved by the end of observation. A significant rise in the mean CD4(+) lymphocyte l evel of HIV subjects occurred after administration of 10 mg/kg andrographol ide (from a baseline of 405 cells/mm(3) to 501 cells/mm(3); p = 0.002), The re were no statistically significant changes in mean plasma HIV-1 RNA level s throughout the trial, Andrographolide may inhibit HIV-induced cell cycle dysregulation, leading to a rise in CD4(+) lymphocyte levels in HIV-1 infec ted individuals, Copyright (C) 2000 John Wiley & Sons, Ltd.