Status:
COMPLETED
Pharmacokinetic Interaction Study of Efavirenz and American Ginseng in Healthy Volunteers
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Healthy Volunteers
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief Summary
This is a 4-week sequential drug interaction study to measure the effects of American ginseng on efavirenz pharmacokinetics using steady-state 24-hour Area Under the Curve (AUC) and Cmax as the primar...
Detailed Description
This study is supported by R01AT005526-01 grant awarded by National Center for Complementary and. Alternative Medicine (NCCAM) to evaluate the safety, efficacy, and mechanism of American ginseng in HI...
Eligibility Criteria
Inclusion
- All enrollees will be healthy volunteers, ≥18 years of age with
- Negative HIV-1 serology, documented by any licensed ELISA test kit
- Ability and willingness to provide a signed informed consent and comply with study requirements
- Males only because efavirenz has been reported to have teratogenic properties
- Estimated creatinine clearance ≥50 mL/minute, as calculated by the Cockcroft-Gault method
- Normal laboratory and physical examination, as judged by the Principal Investigator
- Good peripheral venous access
- Willingness and ability to take oral medications.
Exclusion
- Known or suspected hypersensitivity to American Ginseng (AG) or efavirenz
- Taking any prescription, over-the-counter medication, or Complementary and alternative medicine (CAM) agents within 30 days of study enrolment
- Evidence of active drug or alcohol abuse
- Any other medical or psychological condition that might, in the opinion of the investigator, interfere with participation in the study or put subjects at undue risk
- Hospitalization or therapy for serious illness within 30 days prior to study entry, as judged by the investigator
- Participation in any investigational drug trials within 30 days prior to study entry that, in the opinion of the investigator, would preclude study participation.
Key Trial Info
Start Date :
September 28 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 14 2011
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01136928
Start Date
September 28 2010
End Date
March 14 2011
Last Update
June 15 2018
Active Locations (1)
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1
Johns Hopkins University
Baltimore, Maryland, United States, 21287-5554