Track topics on Twitter Track topics that are important to you
This is a 4-week sequential drug interaction study to measure the effects of American ginseng on efavirenz pharmacokinetics using steady-state 24-hour 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.
This study is supported by R01AT005526-01 grant awarded by NCCAM to evaluate the safety, efficacy, and mechanism of American ginseng in HIV-related fatigue. This is a 4-week sequential drug interaction study to measure the effects of American ginseng on efavirenz pharmacokinetics using steady-state 24-hour 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. Therefore, this study will evaluate the effects of American ginseng on efavirenz plasma concentrations. Only efavirenz plasma concentrations will be measured in this study. American ginseng plasma concentrations will not be assessed in this study. Efavirenz plasma concentrations will be measured on study Days 14 and 28 (corresponding to weeks 2 and 4, respectively).
This is an important study because although American ginseng is a popular dietary supplement, the safety and efficacy of this agent in HIV-infected patients has not yet been established. A major concern regarding the safety of American ginseng in HIV-infected patients is the potential for herb-drug interactions that could alter the metabolism of antiretroviral drugs. Induction of drug metabolizing enzymes by dietary supplements such as American ginseng, could lead to a reduction in the therapeutic concentrations of these drugs and treatment failure. Inhibition of these drug metabolizing enzymes, on the other hand, could result in higher plasma concentrations of antiretroviral agents and potentially lead to increased toxicity.
Most antiretroviral drugs are metabolized by the cytochrome P450 (CYP450) isoenzyme CYP3A4. Our preliminary data suggest that American ginseng does not significantly affect CYP3A4 activity in vivo. A recent study has also reported that the American ginseng-mediated induction of UDP-glucuronosyltransferase enzyme involved in the metabolism of the nucleoside reverse transcriptase inhibitors (NRTIs) zidovudine and abacavir, and the integrase inhibitor raltegravir, does not significantly alter zidoduvine pharmacokinetics. However, data are not available concerning the effect of American ginseng on other major CYP 450 isoforms involved in the metabolism of antiretroviral drugs. For instance, the non- nucleoside reverse transcriptase inhibitor (NNRTI) efavirenz is also metabolized by CYP2B6 and only to a lesser extent by the CYP3A4 isoform. Therefore, a potential drug interaction between American ginseng and this popular NNRTI must be excluded before this herb can be safely used in HIV-infected patients. This study will complete the work that has been currently done characterizing the effects of American ginseng on major drug metabolizing enzymes.
The total duration of this study is five weeks. Participants will receive study medications during the first four weeks of the study. On week 5 participants will complete their final post treatment safety study visit.
POPULATION AND SAMPLE SIZE:
Fifteen adult healthy male volunteers will be enrolled in this study.
Period 1 Days 0-14 Daily efavirenz monotherapy 600 mg orally Efavirenz pharmacokinetic sampling on Day 14
Period 2 Days 15-28 Daily efavirenz 600 mg orally PLUS American ginseng 3000 mg orally Efavirenz pharmacokinetic sampling on Day 28
Because efavirenz is a Category D drug with positive evidence of fetal risk, only male healthy volunteers will be enrolled in this study. Our 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.
Control: Uncontrolled, Intervention Model: Single Group Assignment, Masking: Open Label
Johns Hopkins University
Not yet recruiting
Johns Hopkins University
Published on BioPortfolio: 2014-08-27T03:13:10-0400
RATIONALE: American ginseng may reduce fatigue in patients with cancer. It is not yet known whether American ginseng is more effective than a placebo in treating cancer-related fatigue. ...
This research project will determine the safety and tolerability of ginseng in subjects with MS and will gather preliminary data on the efficacy of ginseng vs placebo for the treatment of ...
This randomized pilot trial studies how well North American ginseng extract AFX-2 (ginseng) works in decreasing cancer-related fatigue after treatment in cancer survivors. Ginseng may decr...
To determine the effect of polysaccharides from American ginseng root on postprandial glycemia in healthy individuals.
The study is a 2 phase double blind randomized placebo control trial. The objective is to asses the metabolic and therapeutic effects of American Ginseng (Panax quinquefolius L.) extract a...
The pharmacokinetics (PK) of β-lactam antibiotics in cystic fibrosis (CF) patients has been compared with that in healthy volunteers for over four decades; however, no quantitative models exist that ...
TP0463518 is a novel hypoxia-inducible factor prolyl hydroxylase inhibitor developed to aid in the treatment of anemia associated with chronic kidney disease (CKD) and is expected to increase erythrop...
As with all early-stage testing of investigational drugs, clinical trials targeting HIV/AIDS can pose unknown risks to research subjects. Unlike sick participants seeking a therapeutic benefit, the mo...
Inflammatory bowel disease (IBD) is a significant public health problem in the United States. Abdominal pain is a major complaint among individuals with IBD. Successful IBD management not only control...
Understanding the pharmacokinetics in cystic fibrosis (CF) patients is important for dosing. For antibiotics with extensive metabolism, however, a comparison of metabolite formation and elimination be...
Persons with no known significant health problems who are recruited to participate in research to test a new drug, device, or intervention as controls for a patient group. (from http://clinicalcenter.nih.gov/recruit/volunteers.html, accessed 2/14/2013)
Hospital or other institutional ethics committees established to consider the ethical dimensions of patient care. Distinguish from ETHICS COMMITTEES, RESEARCH, which are established to monitor the welfare of patients or healthy volunteers participating in research studies.
Human experimentation that is not intended to benefit the subjects on whom it is performed. Phase I drug studies (CLINICAL TRIALS, PHASE I AS TOPIC) and research involving healthy volunteers are examples of nontherapeutic human experimentation.
Healthy People Programs are a set of health objectives to be used by governments, communities, professional organizations, and others to help develop programs to improve health. It builds on initiatives pursued over the past two decades beginning with the 1979 Surgeon General's Report, Healthy People, Healthy People 2000: National Health Promotion and Disease Prevention Objectives, and Healthy People 2010. These established national health objectives and served as the basis for the development of state and community plans. These are administered by the Office of Disease Prevention and Health Promotion (ODPHP). Similar programs are conducted by other national governments.
A plant genus in the family ARALIACEAE, order Apiales, subclass Rosidae. It is best known as an adaptogen and a substitute for ginseng.
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...