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A PHASE I TRIAL OF ANDROGRAPHOLIDE IN HIV POSITIVE PATIENTS AND NORMAL VOLUNTEERS

Abstract no :  4-1..4-DG-054
Author(s) :  Calabrese, C.; Berman, S.H.; Babish, J.G.; Ma, X.; Shinto, L.; Dorr. M.; Wells. K.; Wells, K.; Wenner,C. A.; Standish, LJ
Address :  (Bastyr University Research Institute, Bastyr University, Washington, USA)
Source :  Phytotherapy Research, v. 14(5): p. 333-338, 2000
Title :  A PHASE I TRIAL OF ANDROGRAPHOLIDE IN HIV POSITIVE PATIENTS AND NORMAL VOLUNTEERS
Abstract :      A phase 1 dose-escalating clinical trial of andrographolide from Andrographis paniculata (BHUNIMBA) was conducted in 13HIV positive patients and five HIV uninfected, healthy volunteers. No subjects used antiretroviral medications during the trial. The planned regimen was 5 mg/kg bodyweight for 3 weeks, escalating to l0 mg/kg bodyweight for 3 weeks, and to 20 mg/kg bodyweight for a final 3 weeks. A significant rise in the mean CD4+ lymphocyte level of HIV subject occurred after administration of 10 mg/kg andrographolide. There were no statistically significant changes in mean plasma HIV-1 RNA levels throughout the trial. Andrographolide has been suggested to inhibit HIV-induced cell cycle deregulation, leading to a rise in CD4+ lymphocyte levels in HIV-1 infected individuals.

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