Prospective Epidemiological Study Of The Prevalence Of HL... | NCT00453440

Studies
Prospective Epidemiological Study Of The Prevalence Of HLA-B*5701

NCT00453440

Sponsor

ViiV Healthcare

Status

Completed

Last Update Posted

Sep 12, 2017Actual

Enrollment

1,502Actual

Phase

Not provided

Conditions

Infection, Human Immunodeficiency Virus

Interventions

Cheek swab & blood test

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 20, 2007Actual

Primary Completion Date

Aug 10, 2007Actual

Completion Date

Aug 10, 2007Actual

First Submitted Date

Mar 28, 2007

First Submission Date that Met QC Criteria

Mar 28, 2007

First Posted Date

Mar 29, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 9, 2017

Last Update Posted Date

Sep 12, 2017Actual

Name	Class
GlaxoSmithKline	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

1,502Actual

Name	Type	Description	Arm Group Labels	Other Names
Cheek swab & blood test	Procedure	Cheek swab & blood test

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
Prevalence of HLA-B*5701 in major UK ethnotypes in the study population.		2 Hours
Description of HLA-B*5701 in the UK population via local labs.		2 Hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

HIV-1 infected patients over 18 years of age
Patient willing & able to understand and provide written informed consent

Exclusion criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
GSK Clinical Trials	ViiV Healthcare	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Woolwich, London	London	SE18 4QH	United Kingdom
GSK Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19780860	Derived	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.

ID	Term
D007239	Infections
D000163	Acquired Immunodeficiency Syndrome
D015658	HIV Infections

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D015229	Sexually Transmitted Diseases, Viral
D012749	Sexually Transmitted Diseases

ID	Term
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D008919	Investigative Techniques