Pharmacokinetic Interaction Study of Efavirenz and American Ginseng in Healthy Volunteers

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01136928
• Date of registration: 02/06/2010
• Primary sponsor: Johns Hopkins University
• Public title: Pharmacokinetic Interaction Study of Efavirenz and American Ginseng in Healthy Volunteers
• Scientific title: Phase I Pharmacokinetic Interaction Study of Efavirenz and American Ginseng in Healthy Volunteers
• Date of first enrolment: July 2010
• Target sample size: 15
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT01136928
• Study type: Interventional
• Study design: Intervention Model: Single Group Assignment, Masking: Open Label

Countries of recruitment

United States

Contacts

• Name: Adriana Andrade, MD, MPH
• Affiliation: Johns Hopkins University

Key inclusion & exclusion criteria

Inclusion Criteria:

1. All enrollees will be healthy volunteers, =18 years of age with

2. Negative HIV-1 serology, documented by any licensed ELISA test kit

3. Ability and willingness to provide a signed informed consent and comply with study
requirements

4. Males only because efavirenz has been reported to have teratogenic properties

5. Estimated creatinine clearance =50 mL/minute, as calculated by the Cockcroft-Gault
method

6. Normal laboratory and physical examination, as judged by the Principal Investigator

7. Good peripheral venous access

8. Willingness and ability to take oral medications.

Exclusion Criteria:

1. Known or suspected hypersensitivity to AG or efavirenz

2. Taking any prescription, over-the-counter medication, or CAM agents within 30 days of
study enrolment

3. Evidence of active drug or alcohol abuse

4. 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

5. Hospitalization or therapy for serious illness within 30 days prior to study entry,
as judged by the investigator

6. Participation in any investigational drug trials within 30 days prior to study entry
that, in the opinion of the investigator, would preclude study participation.



Age minimum: 18 Years
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Healthy Volunteers

Intervention(s)

Drug: American ginseng

Primary Outcome(s)

To compare efavirenz AUC0-24 and Cmax when dosed alone to steady-state efavirenz AUC0-24 and Cmax given concurrently with American ginseng. Efavirenz AUC0-24 with and without American ginseng [Time Frame: 14 days of efavirenz alone, followed by 14 days of concurrent administration of efavirenz and American ginseng]

Secondary Outcome(s)

Efavirenz Clearance with and without American ginseng [Time Frame: 14 days of efavirenz alone, followed by 14 days of concurrent administration of efavirenz and American ginseng]

Efavirenz Cmin with and without American ginseng [Time Frame: 14 days of efavirenz alone, followed by 14 days of concurrent administration of efavirenz and American ginseng]

Efavirenz T1/2 with and without American ginseng [Time Frame: 14 days of efavirenz alone, followed by 14 days of concurrent administration of efavirenz and American ginseng]

Efavirenz tmax with and without American ginseng [Time Frame: 14 days of efavirenz alone, followed by 14 days of concurrent administration of efavirenz and American ginseng]

Secondary ID(s)

NA_00038067

R01AT005526-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Center for Complementary and Alternative Medicine (NCCAM)