Status:
COMPLETED
Genetic Determinants of the Metabolism of Non-nucleoside Reverse Transcriptase Inhibitors
Lead Sponsor:
Vanderbilt University
Conditions:
HIV Infections
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
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.
Eligibility Criteria
Inclusion
- Healthy African American men and women.
- 18-55 years of age.
- Willing and able to provide written informed consent.
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00730223
Start Date
March 1 2004
End Date
August 1 2009
Last Update
February 15 2013
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