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

February 15, 2007
October 13, 2008
March 2007
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Complete list of historical versions of study NCT00435838 on ClinicalTrials.gov Archive Site
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A Study of Patient Management in HIV-1 Infected Patients Found to Have the Genetic Marker HLA-B*5701
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Observational Study to Evaluate Disease Management and Adverse Events in Adult Subjects With HIV-1 Infection Who Were Withdrawn From CNA106030 Due to a Positive HLA-B*5701 Test Result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

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Observational
Time Perspective: Retrospective
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HIV Infection
Drug: No Intervention -- Observational study
Other Name: No Intervention -- Observational study
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
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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not to receive abacavir in the CNA106030 study because of a positive HLA-B*5701 screen result, and were subsequently withdrawn from protocol CNA106030.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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   Italy,   Russian Federation,   Slovenia,   Spain,   Switzerland
 
NCT00435838
CNA108223
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Study Director, GSK
GlaxoSmithKline
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Study Director: GSK Clinical Trials, PhD GlaxoSmithKline
GlaxoSmithKline
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP