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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00435838
First received: February 15, 2007
Last updated: October 13, 2008
Last verified: October 2008
History of Changes
  Purpose

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 Intervention
HIV Infection
 Drug: No Intervention -- Observational study

Study Type: Observational
Study Design: 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Observational Study to Evaluate Disease Management and Adverse Events in Adult Subjects With HIV-1 Infection Who Were Withdrawn From CNA106030 Due to a Positive HLA-B*5701 Test Result

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Estimated Enrollment: 35
Study Start Date: March 2007
Intervention Details:
    Drug: No Intervention -- Observational study
    Other Name: No Intervention -- Observational study
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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not to receive abacavir in the CNA106030 study because of a positive HLA-B*5701 screen result, and were subsequently withdrawn from protocol CNA106030.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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00435838

Locations
Austria
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-1140
GSK Investigational Site
Vienna, Austria, A-1090
Belgium
GSK Investigational Site
Brussels, Belgium, 1070
GSK Investigational Site
Bruxelles, Belgium, 1000
Italy
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
Slovenia
GSK Investigational Site
Ljubljana, Slovenia, 1000
Spain
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
Switzerland
GSK Investigational Site
La Chaux-de-Fonds, Switzerland, CH 2301
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, PhD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00435838     History of Changes
Other Study ID Numbers: CNA108223
Study First Received: February 15, 2007
Last Updated: October 13, 2008
Health Authority: Italy: Ministry of Health

Keywords provided by GlaxoSmithKline:
HLa-B*5701 Abacavir

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

ClinicalTrials.gov processed this record on May 23, 2013