A Phase I Study on the Safety of Echinacea angustifolia
and its Effect on Viral Load in HIV Infected Individuals

This section is compiled by Frank M. Painter, D.C.
Send all comments or additions to:    Frankp@chiro.org

JANA 1998;   1 (1):   14–17

See D, Berman S, Justis J, Broumand N, Chou S, Chang J, Tilles J

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Effective treatment of HIV infection is likely to require both antiviral chemotherapy and reconstitution of the immune system. Many immunomodulatory agents have been tested previously. Echinacea angustifolia (EA) has shown considerable immunomodulatory activity in vitro. A phase I trial of EA in HIV (+) individuals was conducted. Fourteen patients with CD4 counts ranging from 6 to 600/mm3 (mean 269) and viral loads (log10) ranging from 2.3 to 5.4 (mean 4.68) were enrolled and the 14/15 subjects who completed the study included in the analyses. Each had been on a stable antiretroviral regimen or no antiretrovirals for at least the previous 12 weeks. Each received a 12-week course of EA at 1000 mg tid. HIV viral loads, CD4 counts, Natural Killer (NK) cell killing activity against K562 target cells, clinical assessment, and lab monitoring for toxicity were done every two weeks. There were no clinical or laboratory toxicities noted during the study. At 12 weeks there was no significant difference in mean CD4 count compared to baseline. However, there was an overall 0.32 log10 reduction in viral load (mean 4.36, p<.05). EA did not demonstrate any direct anti-HIV killing activity in vitro and there was no change in NK activity. Thus, EA was safe and associated with a significant reduction in viral load in HIV (+) individuals in this pilot study. The mechanism is presumably immunologic although NK killing activity against K562 cells was unchanged.

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