Preference of Genetic Polymorphism and Pharmacokinetics
This study has been completed.
Sponsor:
Chinese University of Hong Kong
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
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| Ages Eligible for Study: | Child, Adult, Senior |
| 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
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
| 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 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 |
ClinicalTrials.gov processed this record on September 26, 2016