Annals of internal medicine · 1999
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.
Клиническое исследованиеКлиническое исследование I фазыСтатьяМногоцентровое исследованиеПоддержка службы здравоохранения СШАНазвание и аннотация: Перевод пока не подготовлен
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Gulick R M, McAuliffe V, Holden-Wiltse J, Crumpacker C, Liebes L, Stein D S, Meehan P, Hussey S, Forcht J, Valentine F T
Аннотация
BACKGROUND: Hypericin, the active compound in St. John's Wort, has antiretroviral activity in vitro. Many HIV-infected persons use St. John's wort.
OBJECTIVE: To evaluate the safety and antiretroviral activity of hypericin in HIV-infected patients.
DESIGN: Phase I study.
SETTING: Four clinical research units.
PATIENTS: 30 HIV-infected patients with CD4 counts less than 350 cells/mm3.
INTERVENTION: 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.
MEASUREMENTS: 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.
RESULTS: 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.
CONCLUSIONS: Hypericin caused significant phototoxicity and had no antiretroviral activity in the limited number of patients studied.
OBJECTIVE: To evaluate the safety and antiretroviral activity of hypericin in HIV-infected patients.
DESIGN: Phase I study.
SETTING: Four clinical research units.
PATIENTS: 30 HIV-infected patients with CD4 counts less than 350 cells/mm3.
INTERVENTION: 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.
MEASUREMENTS: 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.
RESULTS: 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.
CONCLUSIONS: Hypericin caused significant phototoxicity and had no antiretroviral activity in the limited number of patients studied.