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Effects of CYP2B6 Genetic Polymorphisms on Efavirenz Pharmacokinetics

NCT00668395 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2014-09-26

Study results available
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Summary

1. To see how the liver breaks down efavirenz by an enzyme called CYP2B6. It is suggested that when Efavirenz is taken repeatedly it may increase the amount of CYP2B6 in your liver and thus speed up your liver's ability to get rid of efavirenz from your body. This may render efavirenz and other medications ineffective.
2. To see how efavirenz interact with other drugs taken at the same time with it.
3. To see if genetic differences can change the way how the liver breaks down efavirenz and its interactions with other co-administered drugs.

Conditions

Interventions

DRUG

Efavirenz

The metabolism and pharmacokinetics of efavirenz were assessed at a single 600 mg oral dose of efavirenz and after subjects took multiple doses of efavirenz (600 mg/day orally for 17 days).

Sponsors & Collaborators

  • Indiana University

    lead OTHER

Principal Investigators

  • Zeruesenay Desta, PhD · Indiana University

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2010-04-30
Completion
2010-04-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00668395 on ClinicalTrials.gov