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Preference of Genetic Polymorphism and Pharmacokinetics

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ClinicalTrials.gov Identifier: NCT01658371
Recruitment Status : Completed
First Posted : August 7, 2012
Last Update Posted : August 7, 2012
Sponsor:
Information provided by (Responsible Party):
To Kin Wang, Chinese University of Hong Kong

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease
HIV

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

Study Design
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Observational
Actual Enrollment : 100 participants
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
Study Start Date : May 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Efavirenz
U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
efavirenz
HIV patients on efavirenz


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. pharmacokinetics [ Time Frame: 24 hour ]
    This includes plasma concentration of drugs in relation to time, in different genotypes


Secondary Outcome Measures :
  1. genotypes frequency [ Time Frame: 1 year ]

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Inclusion Criteria:

  • Southern Chinese HIV patients on efavirenz

Exclusion Criteria:

  • Refuse to sign consent, HIV patients not on efavirenz
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01658371


Locations
China, Hong Kong
The Chinese University of Hong Kong
Hong Kong, Hong Kong, China
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: S S Lee, Professor Chinese University of Hong Kong
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: To Kin Wang, Specialist, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01658371     History of Changes
Other Study ID Numbers: CRE-2008.180
First Posted: August 7, 2012    Key Record Dates
Last Update Posted: August 7, 2012
Last Verified: August 2012

Keywords provided by To Kin Wang, Chinese University of Hong Kong:
HIV

Additional relevant MeSH terms:
Efavirenz
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