HIVNCT01658371
Preference of Genetic Polymorphism and Pharmacokinetics
An observational study of HIV, run by Chinese University of Hong Kong at 1 site in China.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HIV
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- May 2008to Jun 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Southern Chinese HIV patients
Who may be able to join
- Southern Chinese HIV patients on efavirenz
Who cannot join
- Refuse to sign consent, HIV patients not on efavirenz
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preference of CYP450 2B6 516 G>T Polymorphism and Pharmacokinetics of Plasma Efavirenz in A Group of HIV Infected Southern Chinese
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.
Read the detailed description
Eligible patients are invited to donate blood samples for pharmacokinetic study and genotype analysis
- Conditions
- HIV
- Keywords
- HIV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| efavirenz | HIV patients on efavirenz |
What is being measured
The primary outcome is the main question the study is designed to answer.
pharmacokinetics
This includes plasma concentration of drugs in relation to time, in different genotypes
Measured: 24 hour
Secondary outcomes (1)
genotypes frequency
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2012 (estimated)
- Study startMay 2008
- Primary completionDec 2009
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, To Kin Wang, Chinese University of Hong Kong
- Investigators
- S S Lee, Professor, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01658371
- Sponsor's protocol ID
- CRE-2008.180
- Status last verified
- Aug 2012
- First submitted
- 27 Feb 2012
- Last updated
- 7 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preference of CYP450 2B6 516 G>T Polymorphism and Pharmacokinetics of Plasma Efavirenz in A Group of HIV Infected Southern Chinese
- ClinicalTrials.gov ID
- NCT01658371
- Acronym / sponsor ID
- CRE-2008.180
- Conditions
- HIV
- Keywords
- HIV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 7 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Eligible patients are invited to donate blood samples for pharmacokinetic study and genotype analysis
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| efavirenz | – | –HIV patients on efavirenz |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Southern Chinese HIV patients
Key inclusion criteria (1 listed)
- Southern Chinese HIV patients on efavirenz
Key exclusion criteria (1 listed)
- Refuse to sign consent, HIV patients not on efavirenz
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
pharmacokinetics
Time frame: 24 hour
This includes plasma concentration of drugs in relation to time, in different genotypes
1 secondary outcome
genotypes frequency
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
S S Lee, Professor principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV, run by Chinese University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pharmacokinetics (time frame: 24 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2012.