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HLA-B*5701 And Hypersensitivity To Abacavir

This study has been completed.
Study NCT00373945.   Last updated on October 13, 2008.   Information provided by GlaxoSmithKline

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Descriptive Information Fields
Brief Title  HLA-B*5701 And Hypersensitivity To Abacavir
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.
Brief Summary

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.

Detailed Description
Study Phase
Study Type  Observational
Study Design  Retrospective
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  HIV Infection
Intervention  Drug: Observational Study
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  280
Start Date  August 2006
Completion Date August 2007
Eligibility 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.
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00373945
Organization ID ABC107442
Secondary IDs †† SHAPE
Study Sponsor  GlaxoSmithKline
Collaborators ††
Investigators 
Study Director:     GSK Clinical Trials, MD     GlaxoSmithKline    
Information Provided By GlaxoSmithKline
Verification Date October 2008
First Received Date  September 7, 2006
Last Updated Date October 13, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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