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

October 13, 2008 updated by: GlaxoSmithKline

A Retrospective, Multi-Centre Observational Study to Evaluate Disease Management and Adverse Events in Adult Subjects With HIV-1 Infection Who Were Withdrawn From CNA106030 Due to a Positive HLA-B*5701 Test Result

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, A-8020
        • GSK Investigational Site
      • Innsbruck, Austria, A-6020
        • GSK Investigational Site
      • Salzburg, Austria, A-5020
        • GSK Investigational Site
      • Vienna, Austria, A-1090
        • GSK Investigational Site
      • Vienna, Austria, A-1140
        • GSK Investigational Site
  • Belgium
      • Brussels, Belgium, 1070
        • GSK Investigational Site
      • Bruxelles, Belgium, 1000
        • GSK Investigational Site
  • Italy
    • Emilia-Romagna
      • Rimini, Emilia-Romagna, Italy, 47900
        • GSK Investigational Site
    • Lazio
      • Roma, Lazio, Italy, 00185
        • GSK Investigational Site
    • Lombardia
      • Legnano (MI, Lombardia, Italy, 20025
        • GSK Investigational Site
      • Milano, Lombardia, Italy, 20142
        • GSK Investigational Site
    • Trentino-Alto Adige
      • Bolzano, Trentino-Alto Adige, Italy, 39100
        • GSK Investigational Site
    • Veneto
      • Padova, Veneto, Italy, 35128
        • GSK Investigational Site
  • Russian Federation
      • Belgorod, Russian Federation, 308036
        • GSK Investigational Site
      • Orel, Russian Federation, 302040
        • GSK Investigational Site
      • Volgograd, Russian Federation, 400040
        • GSK Investigational Site
  • Slovenia
      • Ljubljana, Slovenia, 1000
        • GSK Investigational Site
  • Spain
      • Alcala de Henares, Spain, 28805
        • GSK Investigational Site
      • Alicante, Spain, 03010
        • GSK Investigational Site
      • Badalona, Spain, 08916
        • GSK Investigational Site
      • Barcelona, Spain, 08907
        • GSK Investigational Site
      • Madrid, Spain, 28041
        • GSK Investigational Site
      • Malaga, Spain, 29020
        • GSK Investigational Site
      • Valencia, Spain, 46015
        • GSK Investigational Site
  • Switzerland
      • La Chaux-de-Fonds, Switzerland, CH 2301
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, PhD, GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Study Registration Dates

First Submitted

February 15, 2007

First Submitted That Met QC Criteria

February 15, 2007

First Posted (Estimate)

February 16, 2007

Study Record Updates

Last Update Posted (Estimate)

October 15, 2008

Last Update Submitted That Met QC Criteria

October 13, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CNA108223

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV Infection

Clinical Trials on No Intervention -- Observational study

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Philippines

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe