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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00730223
• Other study ID #: 040062
• Secondary ID: GM31304CFAR Disc
• Status: Completed
• Phase: Phase 1
• First received: August 4, 2008
• Last updated: February 12, 2013
• Start date: March 2004
• Est. completion date: August 2009

Study information

• Verified date: February 2013
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: August 2009
• Est. primary completion date: March 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Nevirapine and Efavirenz
single oral dose 200mg of nevirapine and single oral dose 600 mg of efavirenz

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics of single dose nevirapine and single dose efavirenz		5-6 weeks	Yes