Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Preference of Genetic Polymorphism and Pharmacokinetics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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

Layout table for study 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

Group/Cohort
efavirenz
HIV patients on efavirenz



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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
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

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
Layout table for location information
China, Hong Kong
The Chinese University of Hong Kong
Hong Kong, Hong Kong, China
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Layout table for investigator information
Principal Investigator: S S Lee, Professor Chinese University of Hong Kong
Layout table for additonal information
Responsible Party: To Kin Wang, Specialist, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01658371    
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