Infection, Human Immunodeficiency VirusNCT00453440
Prospective Epidemiological Study Of The Prevalence Of HLA-B*5701
An observational study of Infection, Human Immunodeficiency Virus, run by ViiV Healthcare at 8 sites in United Kingdom.
Trial summary
This is a study to determine the prevalence of a genetic marker, HLA-B5701, in the UK population. HLA-B*5701 has been strongly associated with the risk of an allergic reaction to a HIV medicine, Abacavir. The allergic reaction is known as a hypersensitivity reaction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection, Human Immunodeficiency Virus
- What is being tested?
- Cheek swab & blood test
- Type of treatment
- Surgery or procedure
- How many people
- 1,502 participants
- Where
- 8 sitesUnited Kingdom
- Study dates
- 20 Mar 2007to 10 Aug 2007
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-1 infected patients over 18 years of age
- Patient willing \& able to understand and provide written informed consent
Who cannot join
- None
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United Kingdom8 sites
GSK Investigational Site
Birmingham, Warwickshire, B4 6DH
GSK Investigational Site
Birmingham, WS2 9PS
GSK Investigational Site
London, E1 1BB
GSK Investigational Site
London, E9 6SR
GSK Investigational Site
London, SE1 7EH
GSK Investigational Site
London, SW17 0QT
GSK Investigational Site
London, W2 1NY
GSK Investigational Site
Woolwich, London, London, SE18 4QH
About this study
Official title: Prospective Epidemiological Study of the Prevalence of HLA-B*5701 in HIV-1 Infected UK Patients
This is a study to determine the prevalence of a genetic marker, HLA-B5701, in the UK population. HLA-B*5701 has been strongly associated with the risk of an allergic reaction to a HIV medicine, Abacavir. The allergic reaction is known as a hypersensitivity reaction.
The study is a prospective study inviting HIV-1 positive patients over the age of 18 years to participate. Each participant will complete one study visit. They will be asked for details of their background including their age, sex, ethnicity, country of origin and parental country of origin.
Read more
They will be asked to give two samples to test for the presence of the genetic marker HLA-B*5701. The two samples are:
- A cheek swab
- A blood sample
In selected centres patients may be asked to provide up to two additional blood samples. These samples will be used to help develop and validate new methods of determining HLA-B*5701 testing.
- Conditions
- Infection, Human Immunodeficiency Virus
- Being tested
- Cheek swab & blood test
- Keywords
- HIV, HLA-B*5701, Abacavir hypersensitivity reaction, HIV Infection
- Medical subject headings
- Infections, Acquired Immunodeficiency Syndrome, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cheek swab & blood testProcedure or surgery
Cheek swab \& blood test
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of HLA-B*5701 in the UK population via central labs
The widespread of HLA-B*5701 applied in the selected area in each participant of the UK population was tested via central labs. The result is summarized here.
Measured: 2 Hours
Secondary outcomes (2)
Prevalence of HLA-B*5701 in major UK ethnotypes in the study population.
Measured: 2 Hours
Description of HLA-B*5701 in the UK population via local labs.
Measured: 2 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2007 (estimated)
- Study start20 Mar 2007
- Primary completion10 Aug 2007
- Study completion10 Aug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infection, Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by ViiV HealthcareThe 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
- Enrolment
- 1,502 participants (actual)
Sponsor and investigators
- Lead sponsor
- ViiV Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, ViiV Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00453440
- Sponsor's protocol ID
- CNA109479
- Status last verified
- Sep 2017
- First submitted
- 28 Mar 2007
- Last updated
- 12 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Orkin C, Sadiq ST, Rice L, Jackson F; UK EPI team. Prospective epidemiological study of the prevalence of human leukocyte antigen (HLA)-B*5701 in HIV-1-infected UK subjects. HIV Med. 2010 Mar;11(3):187-92. doi: 10.1111/j.1468-1293.2009.00762.x. Epub 2009 Sep 24.
PubMed 19780860
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Epidemiological Study of the Prevalence of HLA-B*5701 in HIV-1 Infected UK Patients
- ClinicalTrials.gov ID
- NCT00453440
- Acronym / sponsor ID
- CNA109479
- Conditions
- Infection, Human Immunodeficiency Virus
- Keywords
- HIV, HLA-B*5701, Abacavir hypersensitivity reaction, HIV Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,502 participants (actual)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- 20 Mar 2007 (actual)
- Primary completion
- 10 Aug 2007 (actual)
- Study completion
- 10 Aug 2007 (actual)
- First posted
- 29 Mar 2007 (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.
This is a study to determine the prevalence of a genetic marker, HLA-B5701, in the UK population. HLA-B*5701 has been strongly associated with the risk of an allergic reaction to a HIV medicine, Abacavir. The allergic reaction is known as a hypersensitivity reaction.
The study is a prospective study inviting HIV-1 positive patients over the age of 18 years to participate. Each participant will complete one study visit. They will be asked for details of their background including their age, sex, ethnicity, country of origin and parental country of origin.
They will be asked to give two samples to test for the presence of the genetic marker HLA-B*5701. The two samples are:
- A cheek swab
- A blood sample
In selected centres patients may be asked to provide up to two additional blood samples. These samples will be used to help develop and validate new methods of determining HLA-B*5701 testing.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- HIV-1 infected patients over 18 years of age
- Patient willing \& able to understand and provide written informed consent
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cheek swab & blood testCheek swab \& blood test | Procedure or surgery | – |
Primary outcome
Prevalence of HLA-B*5701 in the UK population via central labs
Time frame: 2 Hours
The widespread of HLA-B*5701 applied in the selected area in each participant of the UK population was tested via central labs. The result is summarized here.
2 secondary outcomes
Prevalence of HLA-B*5701 in major UK ethnotypes in the study population.
Time frame: 2 Hours
Description of HLA-B*5701 in the UK population via local labs.
Time frame: 2 Hours
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 12 Sep 2017.
- Derived from this study: PubMed 19780860Orkin C, Sadiq ST, Rice L, Jackson F; UK EPI team. Prospective epidemiological study of the prevalence of human leukocyte antigen (HLA)-B*5701 in HIV-1-infected UK subjects. HIV Med. 2010 Mar;11(3):187-92. doi: 10.1111/j.1468-1293.2009.00762.x. Epub 2009 Sep 24.
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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.
GSK Clinical Trials study director
ViiV Healthcare
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection, Human Immunodeficiency Virus, run by ViiV Healthcare at 8 sites in United Kingdom.
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 2 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 12 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United Kingdom. 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?
Prevalence of HLA-B*5701 in the UK population via central labs (time frame: 2 Hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00453440, which also lists 1 linked publication.
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 12 Sep 2017.