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Trial record 7 of 21 for:    complementary and alternative medicine AND American

Pharmacokinetic Interaction Study of Efavirenz and American Ginseng in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT01136928
Recruitment Status : Completed
First Posted : June 4, 2010
Last Update Posted : June 15, 2018
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Johns Hopkins University

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 primary comparison measures in healthy male volunteers. Efavirenz Cmin, T1/2, tmax, and clearance will also be assessed as secondary outcome measures. This study is a phase I, prospective, within-subject, fixed-order, two-period, multiple dose, open label, drug interaction study, to determine the stead-state plasma pharmacokinetic profile of efavirenz before and after concurrent treatment with American ginseng. The investigators hypothesis is that concurrent oral administration of American ginseng for up to 14 days will not significantly alter the steady-state plasma pharmacokinetic of efavirenz.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: American ginseng Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Phase I Pharmacokinetic Interaction Study of Efavirenz and American Ginseng in Healthy Volunteers
Actual Study Start Date : September 28, 2010
Actual Primary Completion Date : March 14, 2011
Actual Study Completion Date : March 14, 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arm Intervention/treatment
Experimental: American ginseng and efavirenz
This is a sequential study. Healthy volunteers will receive efavirenz alone for 14 days followed by efavirenz plus American ginseng for an additional 14 days.
Drug: American ginseng
Healthy volunteers will ge given efavirnez 600 mg daily monotherapy for 14 days followed by efavirenz 600 mg PLUS American ginseng 3000 mg daily for an additional 14 days.
Other Name: Efavienz (Sustiva)




Primary Outcome Measures :
  1. 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 ]
    Compare efavirenz AUC0-24 and Cmax when dosed alone at 600 mg daily, to steady-state efavirenz AUC0-24 and Cmax dosed at 600 mg daily and given concurrently with American ginseng 3000 mg daily.


Secondary Outcome Measures :
  1. 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 ]
    To compare efavirenz tmax at steady-state when dosed alone as 600 mg daily, to steady-state efavirenz tmax dosed at 600 mg daily and given concurrently with American ginseng 3000 mg daily in HIV-seronegative healthy male volunteers.

  2. 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 ]
    To compare efavirenz Cmin at steady-state when dosed alone as 600 mg daily, to steady-state efavirenz Cmin dosed at 600 mg daily and given concurrently with American ginseng 3000 mg daily in HIV-seronegative healthy male volunteers.

  3. 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 ]
    To compare efavirenz Clearance at steady-state when dosed alone as 600 mg daily, to steady-state efavirenz Clearance dosed at 600 mg daily and given concurrently with American ginseng 3000 mg daily in HIV-seronegative healthy male volunteers

  4. 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 ]
    To compare efavirenz T1/2 at steady-state when dosed alone as 600 mg daily, to steady-state efavirenz T1/2 dosed at 600 mg daily and given concurrently with American ginseng 3000 mg daily in HIV-seronegative healthy male volunteers



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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 American Ginseng (AG) or efavirenz
  2. Taking any prescription, over-the-counter medication, or Complementary and alternative medicine (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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01136928


Locations
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287-5554
Sponsors and Collaborators
Johns Hopkins University
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: Adriana Andrade, MD, MPH Johns Hopkins University

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01136928     History of Changes
Other Study ID Numbers: NA_00038067
R01AT005526-01 ( U.S. NIH Grant/Contract )
First Posted: June 4, 2010    Key Record Dates
Last Update Posted: June 15, 2018
Last Verified: June 2018

Keywords provided by Johns Hopkins University:
Antiretroviral therapy
American ginseng
Efavirenz
Cytochrome P450 enzymes
Complementary and Alternative Medicine
Herbal
Pharmacikinetics
Healthy volunteers

Additional relevant MeSH terms:
Efavirenz
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers