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

Carlo Calabrese, Sheryl H. Berman, John G. Babish, Ma Xinfang, Lynne Shinto, Melissa Dorr, Kameron Wells, Cynthia A. Wenner, Leanna J. Standish

Research output: Contribution to journalArticle

273 Scopus citations

Abstract

A phase I dose-escalating clinical trial of andrographolide from Andrographis paniculata was conducted in 13 HIV positive patients and five HIV uninfected, healthy volunteers. The objectives were primarily to assess safety and tolerability and secondarily to assess effects on plasma virion HIV-1 RNA levels and CD4+ lymphocyte levels. No subjects used antiretroviral medications during the trial. Those with liver or renal abnormalities were excluded. 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 weeks. The trial was interupted 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 level of HIV subjects occurred after administration of 10 mg/kg andrographolide (from a baseline of 405 cells/mm3 to 501 cells/mm3; p = 0.002). There were no statistically significant changes in mean plasma HIV-1 RNA levels throughout the trial. Andrographolide may inhibit HIV-induced cell cycle dysregulation, leading to a rise in CD4+ lymphocyte levels in HIV-1 infected individuals. Copyright (C) 2000 John Wiley and Sons, Ltd.

Original languageEnglish (US)
Pages (from-to)333-338
Number of pages6
JournalPhytotherapy Research
Volume14
Issue number5
DOIs
StatePublished - Sep 9 2000

Keywords

  • AIDS
  • Andrographis paniculata
  • Andrographolide
  • CD4 lymphocytes
  • HIV-1

ASJC Scopus subject areas

  • Pharmacology

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    Calabrese, C., Berman, S. H., Babish, J. G., Xinfang, M., Shinto, L., Dorr, M., Wells, K., Wenner, C. A., & Standish, L. J. (2000). A phase I trial of andrographolide in HIV positive patients and normal volunteers. Phytotherapy Research, 14(5), 333-338. https://doi.org/10.1002/1099-1573(200008)14:5<333::AID-PTR584>3.0.CO;2-D