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NCT01658371 Clinical Trial

Preference of Genetic Polymorphism and Pharmacokinetics

HIV Clinical Trial

Official title:
Preference of CYP450 2B6 516 G>T Polymorphism and Pharmacokinetics of Plasma Efavirenz in A Group of HIV Infected Southern Chinese

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01658371
Other study ID # CRE-2008.180
Secondary ID
Status Completed
Phase N/A
First received February 27, 2012
Last updated August 2, 2012
Start date May 2008
Est. completion date June 2010

Study information
Verified date August 2012
Source Chinese University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
Study type Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date June 2010
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Southern Chinese HIV patients on efavirenz

Exclusion Criteria:

- Refuse to sign consent, HIV patients not on efavirenz

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
China The Chinese University of Hong Kong Hong Kong Hong Kong

Sponsors (1)
Lead Sponsor Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary pharmacokinetics This includes plasma concentration of drugs in relation to time, in different genotypes 24 hour No
Secondary genotypes frequency 1 year No
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