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A Study of Patient Management in HIV-1 Infected Patients Found to Have the Genetic Marker HLA-B*5701

NCT ID: NCT00435838

Last Updated: 2008-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-03-31

Brief Summary

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This is a retrospective observational study which follows on from CNA106030 (a study evaluating whether prospective genetic screening for HLA-B\*5701 can reduce the incidence of hypersensitivity reactions to abacavir). This study aims to collect data on approximately 35 subjects who withdrew from CNA106030 when found to be HLA-B\*5701 positive. HIV disease management and adverse event data in these subjects, where the risk/benefit ratio of treatment with abacavir may alter subsequent prescribing, will be collected

Detailed Description

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Conditions

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HIV Infection

Keywords

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HLa-B*5701 Abacavir

Study Design

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Study Time Perspective

RETROSPECTIVE

Interventions

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No Intervention -- Observational study

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects who have received notification not to receive abacavir in the CNA106030 study because of a positive HLA-B\*5701 screen result, and were subsequently withdrawn from protocol CNA106030.
* Subjects willing and able to understand and provide written informed consent prior to participation in this study.
* French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.

Exclusion Criteria

* Subjects who were not enrolled in the CNA106030 study
* Subjects who are not HLA-B\*5701 positive
* Subjects who do not consent to being told their HLA-B\*5701 status
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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GSK

Principal Investigators

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GSK Clinical Trials, PhD

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Graz, , Austria

Site Status

GSK Investigational Site

Innsbruck, , Austria

Site Status

GSK Investigational Site

Salzburg, , Austria

Site Status

GSK Investigational Site

Vienna, , Austria

Site Status

GSK Investigational Site

Vienna, , Austria

Site Status

GSK Investigational Site

Brussels, , Belgium

Site Status

GSK Investigational Site

Brussels, , Belgium

Site Status

GSK Investigational Site

Rimini, Emilia-Romagna, Italy

Site Status

GSK Investigational Site

Rome, Lazio, Italy

Site Status

GSK Investigational Site

Legnano (MI, Lombardy, Italy

Site Status

GSK Investigational Site

Milan, Lombardy, Italy

Site Status

GSK Investigational Site

Bolzano, Trentino-Alto Adige, Italy

Site Status

GSK Investigational Site

Padua, Veneto, Italy

Site Status

GSK Investigational Site

Belgorod, , Russia

Site Status

GSK Investigational Site

Oryol, , Russia

Site Status

GSK Investigational Site

Volgograd, , Russia

Site Status

GSK Investigational Site

Ljubljana, , Slovenia

Site Status

GSK Investigational Site

Alcalá de Henares, , Spain

Site Status

GSK Investigational Site

Alicante, , Spain

Site Status

GSK Investigational Site

Badalona, , Spain

Site Status

GSK Investigational Site

Barcelona, , Spain

Site Status

GSK Investigational Site

Madrid, , Spain

Site Status

GSK Investigational Site

Málaga, , Spain

Site Status

GSK Investigational Site

Valencia, , Spain

Site Status

GSK Investigational Site

La Chaux-de-Fonds, , Switzerland

Site Status

Countries

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Austria Belgium Italy Russia Slovenia Spain Switzerland

Other Identifiers

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CNA108223

Identifier Type: -

Identifier Source: org_study_id