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Preference of Genetic Polymorphism and Pharmacokinetics

This study has been completed.
Information provided by (Responsible Party):
To Kin Wang, Chinese University of Hong Kong Identifier:
First received: February 27, 2012
Last updated: August 2, 2012
Last verified: August 2012
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 Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Preference of CYP450 2B6 516 G>T Polymorphism and Pharmacokinetics of Plasma Efavirenz in A Group of HIV Infected Southern Chinese

Resource links provided by NLM:

Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • pharmacokinetics [ Time Frame: 24 hour ] [ Designated as safety issue: No ]
    This includes plasma concentration of drugs in relation to time, in different genotypes

Secondary Outcome Measures:
  • genotypes frequency [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: May 2008
Study Completion Date: June 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
HIV patients on efavirenz

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

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Southern Chinese HIV patients

Inclusion Criteria:

  • Southern Chinese HIV patients on efavirenz

Exclusion Criteria:

  • Refuse to sign consent, HIV patients not on efavirenz
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Please refer to this study by its identifier: NCT01658371

China, Hong Kong
The Chinese University of Hong Kong
Hong Kong, Hong Kong, China
Sponsors and Collaborators
Chinese University of Hong Kong
Principal Investigator: S S Lee, Professor Chinese University of Hong Kong
  More Information

Responsible Party: To Kin Wang, Specialist, Chinese University of Hong Kong Identifier: NCT01658371     History of Changes
Other Study ID Numbers: CRE-2008.180 
Study First Received: February 27, 2012
Last Updated: August 2, 2012
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Keywords provided by Chinese University of Hong Kong:

Additional relevant MeSH terms:
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers processed this record on October 27, 2016