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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00435838
Recruitment Status : Completed
First Posted : February 16, 2007
Last Update Posted : October 15, 2008
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Brief Summary:
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

Condition or disease Intervention/treatment
HIV Infection Drug: No Intervention -- Observational study

Study Type : Observational
Enrollment : 35 participants
Time Perspective: Retrospective
Official Title: 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Observational Study to Evaluate Disease Management and Adverse Events in Adult Subjects With HIV-1 Infection Who Were Withdrawn From CNA106030 Due to a Positive HLA-B*5701 Test Result
Study Start Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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not to receive abacavir in the CNA106030 study because of a positive HLA-B*5701 screen result, and were subsequently withdrawn from protocol CNA106030.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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00435838

GSK Investigational Site
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
Brussels, Belgium, 1070
GSK Investigational Site
Bruxelles, Belgium, 1000
GSK Investigational Site
Rimini, Emilia-Romagna, Italy, 47900
GSK Investigational Site
Roma, Lazio, Italy, 00185
GSK Investigational Site
Legnano (MI, Lombardia, Italy, 20025
GSK Investigational Site
Milano, Lombardia, Italy, 20142
GSK Investigational Site
Bolzano, Trentino-Alto Adige, Italy, 39100
GSK Investigational Site
Padova, Veneto, Italy, 35128
Russian Federation
GSK Investigational Site
Belgorod, Russian Federation, 308036
GSK Investigational Site
Orel, Russian Federation, 302040
GSK Investigational Site
Volgograd, Russian Federation, 400040
GSK Investigational Site
Ljubljana, Slovenia, 1000
GSK Investigational Site
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
La Chaux-de-Fonds, Switzerland, CH 2301
Sponsors and Collaborators
Study Director: GSK Clinical Trials, PhD GlaxoSmithKline

Responsible Party: Study Director, GSK Identifier: NCT00435838     History of Changes
Other Study ID Numbers: CNA108223
First Posted: February 16, 2007    Key Record Dates
Last Update Posted: October 15, 2008
Last Verified: October 2008

Keywords provided by GlaxoSmithKline:
HLa-B*5701 Abacavir

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases