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HLA-B*5701 And Hypersensitivity To Abacavir

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ClinicalTrials.gov Identifier: NCT00373945
Recruitment Status : Completed
First Posted : September 8, 2006
Last Update Posted : May 18, 2009
Sponsor:
Information provided by:

Study Description
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

Study Design

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
Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

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

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): NCT00373945


  Show 55 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
More Information

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00373945     History of Changes
Other Study ID Numbers: ABC107442
SHAPE
First Posted: September 8, 2006    Key Record Dates
Last Update Posted: May 18, 2009
Last Verified: May 2009

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

Additional relevant MeSH terms:
HIV Infections
Hypersensitivity
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Abacavir
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