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Ann Intern Med. 1999 Mar 16;130(6):510-4.

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.

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  • 1New York University Medical Center, New York, USA.

Abstract

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.

PMID:
10075619
[PubMed - indexed for MEDLINE]
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