Infection, Human Immunodeficiency Virus INCT00481390
Prospective Epidemiological Study Of The Prevalence Of HLA-B*5701 In HIV-1 Infected Patients
An observational study of Infection, Human Immunodeficiency Virus I and HIV Infection, run by GlaxoSmithKline at 20 sites in 5 countries.
Trial summary
This study is a cross-sectional observational study to evaluate the prevalence of HLA-B*5701 in the European area and in major European ethnotypes. Any HIV-1 infected patient will be eligible for this study including treatment naïve and experienced patients, as well as patients previously tested for HLA-B*5701. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection, Human Immunodeficiency Virus I, HIV Infection, HIV-1 Infection
- What is being tested?
- Cheek cells sample and Blood sample
- Type of treatment
- Surgery or procedure
- How many people
- 1,110 participants
- Where
- 20 sitesin 5 countries
- Study dates
- Jun 2007to Dec 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
Study population: HIV-1 infected adults, out patients department
Who may be able to join
- HIV-1 infected patients over the age of 18 years
- Patient is willing and able to understand and provide written informed consent
Who cannot join
- None
Trial locations and contacts
20 sites in 5 countries.
20 sites in 5 countries
Netherlands10 sites
GSK Investigational Site
Alkmaar, 1815 JD
GSK Investigational Site
Amsterdam, 1105 AZ
GSK Investigational Site
Arnhem, 6815 AD
GSK Investigational Site
Enschede, 7511JX
GSK Investigational Site
Groningen, 9713 GZ
GSK Investigational Site
Maastricht, 6229 HX
GSK Investigational Site
Rotterdam, 3015 GD
GSK Investigational Site
Rotterdam, 3078 HT
GSK Investigational Site
The Hague, 2512 VA
GSK Investigational Site
The Hague, 2545 CH
Switzerland6 sites
GSK Investigational Site
Bern, 3010
GSK Investigational Site
La Chaux-de-Fonds, CH 2301
GSK Investigational Site
Lausanne, 1011
GSK Investigational Site
Lugano, 6900
GSK Investigational Site
Zurich, 8030
GSK Investigational Site
Zurich, 8091
Portugal2 sites
GSK Investigational Site
Amadora, 2720-276
GSK Investigational Site
Lisbon, 1150
About this study
Official title: Prospective Epidemiological Study of the Prevalence of HLA-B*5701 in HIV-1 Infected Patients
This study is a cross-sectional observational study to evaluate the prevalence of HLA-B*5701 in the European area and in major European ethnotypes.
Any HIV-1 infected patient will be eligible for this study including treatment naïve and experienced patients, as well as patients previously tested for HLA-B*5701. Patients will be approached during a standard clinic visit, and will be consented prior to any study specific procedure. They will be asked to provide a tissue sample (cheek cells and blood sample) which will be used to assess HLA-B*5701 status by local and central laboratories.
In selected sites patients may be asked to provide an additional blood sample. This sample will be used to develop and validate different methodologies for assessing HLA-B*5701 status.
- Being tested
- Cheek cells sample, Blood sample
- Keywords
- HIV, HLA-B*5701, prevalence, Treatment Experienced, Treatment Naive
- Medical subject headings
- Infections, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cheek cells sampleProcedure or surgery
Cheek cells sample
Blood sampleProcedure or surgery
Blood sample
| Study group | Role | What they receive |
|---|---|---|
| HIV-1 infected adults | HIV-1 infected adults Receives: Procedure: Cheek cells sample; Procedure: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of HLA-B*5701 in European HIV-1 population
Secondary outcomes (1)
Prevalence of HLA-B*5701 in major European ethnotypes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2007 (estimated)
- Study startJun 2007
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection, Human Immunodeficiency Virus IStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,110 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trials, MD, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00481390
- Sponsor's protocol ID
- CNA110329
- Status last verified
- Jun 2011
- First submitted
- 31 May 2007
- Last updated
- 8 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. 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 Patients
- ClinicalTrials.gov ID
- NCT00481390
- Acronym / sponsor ID
- CNA110329
- Keywords
- HIV, HLA-B*5701, prevalence, Treatment Experienced, Treatment Naive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,110 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 1 Jun 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 study is a cross-sectional observational study to evaluate the prevalence of HLA-B*5701 in the European area and in major European ethnotypes.
Any HIV-1 infected patient will be eligible for this study including treatment naïve and experienced patients, as well as patients previously tested for HLA-B*5701. Patients will be approached during a standard clinic visit, and will be consented prior to any study specific procedure. They will be asked to provide a tissue sample (cheek cells and blood sample) which will be used to assess HLA-B*5701 status by local and central laboratories.
In selected sites patients may be asked to provide an additional blood sample. This sample will be used to develop and validate different methodologies for assessing HLA-B*5701 status.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIV-1 infected adults | – | Procedure: Cheek cells sample, Procedure: Blood sampleHIV-1 infected adults |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV-1 infected adults, out patients department
Key inclusion criteria (2 listed)
- HIV-1 infected patients over the age of 18 years
- Patient is willing and 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 cells sampleCheek cells sample | Procedure or surgery | HIV-1 infected adults |
| Blood sampleBlood sample | Procedure or surgery | HIV-1 infected adults |
Primary outcome
Prevalence of HLA-B*5701 in European HIV-1 population
1 secondary outcome
Prevalence of HLA-B*5701 in major European ethnotypes
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 8 Jun 2011.
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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, MD study director
GlaxoSmithKline
20 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection, Human Immunodeficiency Virus I and HIV Infection, run by GlaxoSmithKline at 20 sites in 5 countries.
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 8 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Netherlands, Switzerland, Portugal, Finland, Ireland. 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 European HIV-1 population. 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 8 Jun 2011.