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

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, see Learn About Clinical Studies.

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 Anti-Infective Agents Anti-Retroviral Agents Antiviral Agents Enzyme Inhibitors	Molecular Mechanisms of Pharmacological Action Nucleic Acid Synthesis Inhibitors Pharmacologic Actions Reverse Transcriptase Inhibitors Therapeutic Uses

ClinicalTrials.gov processed this record on February 26, 2015

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