Infection, Human Immunodeficiency Virus Clinical Trial
Official title:
Prospective Epidemiological Study of the Prevalence of HLA-B*5701 in HIV-1 Infected UK Patients
| Verified date | September 2017 |
| Source | ViiV Healthcare |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 1502 |
| Est. completion date | August 10, 2007 |
| Est. primary completion date | August 10, 2007 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion criteria: - HIV-1 infected patients over 18 years of age - Patient willing & able to understand and provide written informed consent Exclusion criteria: |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | GSK Investigational Site | Birmingham | Warwickshire |
| United Kingdom | GSK Investigational Site | Birmingham | |
| United Kingdom | GSK Investigational Site | London | |
| United Kingdom | GSK Investigational Site | London | |
| United Kingdom | GSK Investigational Site | London | |
| United Kingdom | GSK Investigational Site | London | |
| United Kingdom | GSK Investigational Site | London | |
| United Kingdom | GSK Investigational Site | Woolwich, London | London |
| Lead Sponsor | Collaborator |
|---|---|
| ViiV Healthcare | GlaxoSmithKline |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | 2 Hours | |
| Secondary | Prevalence of HLA-B*5701 in major UK ethnotypes in the study population. | 2 Hours | ||
| Secondary | Description of HLA-B*5701 in the UK population via local labs. | 2 Hours |
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