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Preference of Genetic Polymorphism and Pharmacokinetics

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
To Kin Wang, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01658371
First received: February 27, 2012
Last updated: August 2, 2012
Last verified: August 2012
History of Changes
  Purpose

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
HIV

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:

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

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)
Groups/Cohorts
efavirenz
HIV patients on efavirenz

Detailed Description:

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

  Eligibility

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
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:
HIV

Additional relevant MeSH terms:
Efavirenz
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on June 17, 2013