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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2009-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV Infections

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Interventions

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Nevirapine and Efavirenz

single oral dose 200mg of nevirapine and single oral dose 600 mg of efavirenz

Intervention Type DRUG

Other Intervention Names

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Viramune Sustiva

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes