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HLA-B*5701 And Hypersensitivity To Abacavir

This study has been completed.

Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00373945
  Purpose

This retrospective case-control study is being conducted to estimate the sensitivity of the pharmacogenetic marker, HLA-B*5701 for hypersensitivity to abacavir (ABC HSR). The specificity of the marker, and its association with ABC HSR, as measured by odds ratios and 95% confidence intervals, will be evaluated as secondary endpoints. Cases will be defined in two ways - subjects who have clinically-suspected ABC HSR and a positive abacavir skin patch test reaction (CS-SPTPos) and subjects with clinically-suspected ABC HSR (CS-HSR), regardless of the results of skin patch testing. The study will include 40 CS-SPTPos Black cases matched with up to 200 abacavir-tolerant controls. In parallel, 40 CS-SPTPos White cases will be matched with up to 200 White controls. Some of the secondary analyses will use cases defined by clinical criteria alone (CS-HSR). Black and White subjects will be analyzed separately because of the differences in ABC HSR rates and in the carriage frequency of HLA-B*5701.


Condition Intervention Phase
HIV
Drug: Observational Study
Phase IV

MedlinePlus related topics:   Allergy  

ChemIDplus related topics:   Abacavir   Abacavir sulfate  

U.S. FDA Resources

Study Type:   Observational
Study Design:   Retrospective
Official Title:   A Retrospective Case-Control Study to Estimate the Sensitivity and Specificity of a Pharmacogenetic Marker (HLA-B*5701) in Subjects With and Without Hypersensitivity to Abacavir.

Further study details as provided by GlaxoSmithKline:

Estimated Enrollment:   280
Study Start Date:   August 2006
Study Completion Date:   August 2007

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

Criteria

Inclusion criteria:

  • Subjects with HIV-1 infection with clinically-suspected hypersensitivity to abacavir.
  • Subjects must provide consent for skin patch testing and pharmacogenetic evaluation.

Exclusion criteria:

  • Women found to be pregnant at baseline.
  • Subjects with HIV-1 infection who have tolerated abacavir for at least 12 weeks without experiencing hypersensitivity to the drug.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00373945

 Show 87 Study Locations

Sponsors and Collaborators
GlaxoSmithKline

Investigators
Study Director:     GSK Clinical Trials, MD     GlaxoSmithKline    
  More Information

Study ID Numbers:   ABC107442, SHAPE
First Received:   September 7, 2006
Last Updated:   January 3, 2008
ClinicalTrials.gov Identifier:   NCT00373945
Health Authority:   United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
HLA-B*5701  
pharmacogenetic marker  
hypersensitivity to abacavir,  
retrospective analysis  

Study placed in the following topic categories:
Hypersensitivity
HIV Infections
Acquired Immunodeficiency Syndrome
Abacavir

Additional relevant MeSH terms:
Immune System Diseases

ClinicalTrials.gov processed this record on July 03, 2008




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