HIV Infections
Conditions
Keywords
Nevirapine, Efavirenz, pharmacokinetics, healthy, CYP2B6, HIV/AIDS
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.
Interventions
DRUGNevirapine and Efavirenz
single oral dose 200mg of nevirapine and single oral dose 600 mg of efavirenz
Sponsors
Vanderbilt University
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics of single dose nevirapine and single dose efavirenz | 5-6 weeks |
Outcome results
None listed