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Genetic Determinants of the Metabolism of Non-nucleoside Reverse Transcriptase Inhibitors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00730223
First Posted: August 8, 2008
Last Update Posted: February 15, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
David Haas, Vanderbilt University
August 4, 2008
August 8, 2008
February 15, 2013
March 2004
March 2006   (Final data collection date for primary outcome measure)
Pharmacokinetics of single dose nevirapine and single dose efavirenz [ Time Frame: 5-6 weeks ]
Same as current
Complete list of historical versions of study NCT00730223 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Genetic Determinants of the Metabolism of Non-nucleoside Reverse Transcriptase Inhibitors
Genetic Determinants of the Metabolism of Non-nucleoside Reverse Transcriptase Inhibitors
To see if certain variations in the CYP2B6 gene contribute to differences in plasma drug levels and central nervous system side affects in people who take nevirapine or efavirenz.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
HIV Infections
Drug: Nevirapine and Efavirenz
single oral dose 200mg of nevirapine and single oral dose 600 mg of efavirenz
Other Names:
  • Viramune
  • Sustiva
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
August 2009
March 2006   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy African American men and women.
  • 18-55 years of age.
  • Willing and able to provide written informed consent.

Exclusion Criteria:

  • Currently or recently (within the previous 30 days) received medications known or likely to be metabolized by, or interact wth the CYP450 enzymes.
  • Prior or current hepatic or psychiatric disease illness that in the judgment of the investigator would interfere in the study performance.
  • Active alcohol or illicit drug abuse use that in the judgment of the investigator would interfere in the study performance.
  • Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) >1.5 X upper limit of normal.
  • Positive pregnancy test in women of childbearing potential.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00730223
040062
GM31304
CFAR Discovery Grant
Yes
Not Provided
Not Provided
David Haas, Vanderbilt University
Vanderbilt University
Not Provided
Principal Investigator: David W Haas, MD Associate Professor of Medicine
Vanderbilt University
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP