Genetic Determinants of the Metabolism of Non-nucleoside Reverse Transcriptase Inhibitors
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Nevirapine and Efavirenz
Sponsored by
About this trial
This is an interventional health services research trial for HIV Infections focused on measuring Nevirapine, Efavirenz, pharmacokinetics, healthy, CYP2B6, HIV/AIDS
Eligibility 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.
Sites / Locations
Outcomes
Primary Outcome Measures
Pharmacokinetics of single dose nevirapine and single dose efavirenz
Secondary Outcome Measures
Full Information
NCT ID
NCT00730223
First Posted
August 4, 2008
Last Updated
February 12, 2013
Sponsor
Vanderbilt University
1. Study Identification
Unique Protocol Identification Number
NCT00730223
Brief Title
Genetic Determinants of the Metabolism of Non-nucleoside Reverse Transcriptase Inhibitors
Official Title
Genetic Determinants of the Metabolism of Non-nucleoside Reverse Transcriptase Inhibitors
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Nevirapine, Efavirenz, pharmacokinetics, healthy, CYP2B6, HIV/AIDS
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Nevirapine and Efavirenz
Other Intervention Name(s)
Viramune, Sustiva
Intervention Description
single oral dose 200mg of nevirapine and single oral dose 600 mg of efavirenz
Primary Outcome Measure Information:
Title
Pharmacokinetics of single dose nevirapine and single dose efavirenz
Time Frame
5-6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David W Haas, MD
Organizational Affiliation
Associate Professor of Medicine
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Genetic Determinants of the Metabolism of Non-nucleoside Reverse Transcriptase Inhibitors
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