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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David Haas, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00730223
First received: August 4, 2008
Last updated: February 12, 2013
Last verified: February 2013

August 4, 2008
February 12, 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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00730223 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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.
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00730223
040062, GM31304, CFAR Discovery Grant
Yes
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