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

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Vanderbilt University; Vanderbilt University Medical Center
• Treatments: Efavirenz; Nevirapine; Reverse Transcriptase Inhibitors

Criteria

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.