A Pharmacologically Guided Phase I/II Study of Daily Orally Administered Synthetic Hypericin in HIV-Infected Subjects
Status:
Completed
Trial end date:
1995-01-01
Target enrollment:
Participant gender:
Summary
To determine the safety and tolerance of daily oral hypericin when given to achieve target
trough levels within defined cohorts. To determine the responses of surrogate markers of HIV
infection to daily oral hypericin.
It is not known whether daily oral dosing will produce a tolerable prolonged exposure to
therapeutic levels of hypericin. Pharmacokinetic modeling studies have demonstrated that
daily oral dosing should produce a trough level in a desired range without excessive peak
levels.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)