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HLA-B*5701 And Hypersensitivity To Abacavir
This study has been completed.
First Received: September 7, 2006   Last Updated: May 15, 2009   History of Changes
Sponsor: 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
HIV Infection
Drug: Observational Study

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.

Resource links provided by NLM:


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

No publications provided

Responsible Party: GSK ( Study Director )
Study ID Numbers: ABC107442, SHAPE
Study First Received: September 7, 2006
Last Updated: May 15, 2009
ClinicalTrials.gov Identifier: NCT00373945     History of Changes
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Anti-Infective Agents
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions
Immunologic Deficiency Syndromes
Reverse Transcriptase Inhibitors
Virus Diseases
Hypersensitivity
Anti-Retroviral Agents
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Abacavir
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on November 27, 2009