Roy M. Gulick, MD, MPH; Vincent McAuliffe, MD; Jeanne Holden-Wiltse, MPH; Clyde Crumpacker, MD; Leonard Liebes, PhD; Daniel S. Stein, MD; Patricia Meehan, PhD; Sheila Hussey, RN; Janet Forcht, RN; Fred T. Valentine, MD; for the AIDS Clinical Trials Group 150 and 258 Protocol Teams
Hypericin, the active compound in St. John's Wort, has antiretroviral activity in vitro. Many HIV-infected persons use St. John's wort.
To evaluate the safety and antiretroviral activity of hypericin in HIV-infected patients.
Phase I study.
Four clinical research units.
30 HIV-infected patients with CD4 counts less than 350 cells/mm3.
Intravenous hypericin, 0.25 or 0.5 mg/kg of body weight twice weekly or 0.25 mg/kg three times weekly, or oral hypericin, 0.5 mg/kg daily.
Safety was assessed at weekly visits. Antiretroviral activity was assessed by changes in HIV p24 antigen level, HIV titer, HIV RNA copies, and CD4 cell counts.
Of the 30 patients who were enrolled, 16 discontinued treatment early because of toxic effects. Severe cutaneous phototoxicity was observed in 11 of 23 (48% [95% CI, 27% to 69%]) evaluable patients, and dose escalation could not be completed. Virologic markers and CD4 cell count did not significantly change.
Hypericin caused significant phototoxicity and had no antiretroviral activity in the limited number of patients studied.
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Gulick RM, McAuliffe V, Holden-Wiltse J, Crumpacker C, Liebes L, Stein DS, et al. Phase I Studies of Hypericin, the Active Compound in St. John's Wort, as an Antiretroviral Agent in HIV-Infected Adults: AIDS Clinical Trials Group Protocols 150 and 258. Ann Intern Med. 1999;130:510-514. doi: 10.7326/0003-4819-130-6-199903160-00015
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Published: Ann Intern Med. 1999;130(6):510-514.
HIV, Infectious Disease.
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Print ISSN: 0003-4819 | Online ISSN: 1539-3704
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