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

Vanderbilt University

Status and phase

Completed

Phase 1

Conditions

HIV Infections

Treatments

Drug: Nevirapine and Efavirenz

Study type

Interventional

Funder types

Other

Identifiers

NCT00730223

CFAR Discovery Grant

040062

GM31304

Details and patient eligibility

About

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.

Enrollment

33 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.