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HLA-B*5701 And Hypersensitivity To Abacavir

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: NCT00373945
Recruitment Status : Completed
First Posted : September 8, 2006
Last Update Posted : May 18, 2009
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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.

Condition or disease Intervention/treatment
HIV Infection Drug: Observational Study

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Study Type : Observational
Estimated Enrollment : 280 participants
Time Perspective: 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.
Study Start Date : August 2006
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy 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 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.

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): NCT00373945

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Sponsors and Collaborators
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Study Director: GSK Clinical Trials, MD GlaxoSmithKline

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Responsible Party: Study Director, GSK Identifier: NCT00373945     History of Changes
Other Study ID Numbers: ABC107442
First Posted: September 8, 2006    Key Record Dates
Last Update Posted: May 18, 2009
Last Verified: May 2009
Keywords provided by GlaxoSmithKline:
pharmacogenetic marker
hypersensitivity to abacavir,
retrospective analysis
Additional relevant MeSH terms:
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Immune System Diseases
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents