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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

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

18 Years - 55 Years (Adult)All SexesAccepts 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.

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

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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