Preference of Genetic Polymorphism and Pharmacokinetics

August 2, 2012 updated by: To Kin Wang, Chinese University of Hong Kong

Preference of CYP450 2B6 516 G>T Polymorphism and Pharmacokinetics of Plasma Efavirenz in A Group of HIV Infected Southern Chinese

Genetic polymorphism affects plasma concentration of antiretroviral therapy in HIV patients. The investigators investigate the prevalence of genetic polymorphism affecting efavirenz metabolism and the corresponding pharmacokinetics of different genotypes.

Study Overview

Status

Completed

Conditions

Detailed Description

Eligible patients are invited to donate blood samples for pharmacokinetic study and genotype analysis

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hong Kong
      • Hong Kong, Hong Kong, China
        • The Chinese University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Southern Chinese HIV patients

Description

Inclusion Criteria:

  • Southern Chinese HIV patients on efavirenz

Exclusion Criteria:

  • Refuse to sign consent, HIV patients not on efavirenz

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
efavirenz
HIV patients on efavirenz

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pharmacokinetics
Time Frame: 24 hour
This includes plasma concentration of drugs in relation to time, in different genotypes
24 hour

Secondary Outcome Measures

Outcome Measure
Time Frame
genotypes frequency
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: S S Lee, Professor, Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

February 27, 2012

First Submitted That Met QC Criteria

August 2, 2012

First Posted (Estimate)

August 7, 2012

Study Record Updates

Last Update Posted (Estimate)

August 7, 2012

Last Update Submitted That Met QC Criteria

August 2, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CRE-2008.180

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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