HLA-B*5701 And Hypersensitivity To Abacavir

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00373945
First received: September 7, 2006
Last updated: May 15, 2009
Last verified: May 2009
  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: 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.

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
Intervention Details:
    Drug: Observational Study
    Other Name: Observational Study
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
United States, Alabama
GSK Investigational Site
Birmingham, Alabama, United States, 35294
United States, Arkansas
GSK Investigational Site
Little Rock, Arkansas, United States, 72207
United States, California
GSK Investigational Site
Beverly Hills, California, United States, 90210
GSK Investigational Site
Loma Linda, California, United States, 92357
GSK Investigational Site
Los Angeles, California, United States, 90027
GSK Investigational Site
Los Angeles, California, United States, 90069
GSK Investigational Site
Newport Beach, California, United States, 92663
GSK Investigational Site
Oakland, California, United States, 94609
GSK Investigational Site
San Francisco, California, United States, 94115-1931
GSK Investigational Site
Tarzana, California, United States, 91356
United States, Colorado
GSK Investigational Site
Denver, Colorado, United States, 80220
GSK Investigational Site
Denver, Colorado, United States, 80204
United States, Connecticut
GSK Investigational Site
Norwalk, Connecticut, United States, 06851
United States, Florida
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33316
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33308
GSK Investigational Site
Hollywood, Florida, United States, 33020
GSK Investigational Site
Orlando, Florida, United States, 32803
GSK Investigational Site
Orlando, Florida, United States, 32812
United States, Georgia
GSK Investigational Site
Atlanta, Georgia, United States, 30308
GSK Investigational Site
Atlanta, Georgia, United States, 30309
GSK Investigational Site
Atlanta, Georgia, United States, 30339
GSK Investigational Site
Augusta, Georgia, United States, 30912
United States, Illinois
GSK Investigational Site
Chicago, Illinois, United States, 60657
GSK Investigational Site
Chicago, Illinois, United States, 60612
GSK Investigational Site
Chicago, Illinois, United States, 60637
United States, Kentucky
GSK Investigational Site
Lexington, Kentucky, United States, 40536
United States, Maryland
GSK Investigational Site
Balitmore, Maryland, United States, 21287
GSK Investigational Site
Baltimore, Maryland, United States, 21201
GSK Investigational Site
Baltimore, Maryland, United States, 21229-5299
United States, Massachusetts
GSK Investigational Site
Springfield, Massachusetts, United States, 01107
United States, Michigan
GSK Investigational Site
Detroit, Michigan, United States, 48201
United States, Missouri
GSK Investigational Site
St. Louis, Missouri, United States, 63110
GSK Investigational Site
St. Louis, Missouri, United States, 63108
United States, New York
GSK Investigational Site
Albany, New York, United States, 12208
GSK Investigational Site
Bronx, New York, United States, 10461
GSK Investigational Site
Catskill, New York, United States, 12414
GSK Investigational Site
New York, New York, United States, 10011
GSK Investigational Site
Rochester, New York, United States, 14604
GSK Investigational Site
Valhalla, New York, United States, 10595
United States, North Carolina
GSK Investigational Site
Chapel Hill, North Carolina, United States, 27514
GSK Investigational Site
Greenville, North Carolina, United States, 27834
United States, Ohio
GSK Investigational Site
Akron, Ohio, United States, 44304
United States, Oregon
GSK Investigational Site
Portland, Oregon, United States, 97227
United States, Pennsylvania
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
GSK Investigational Site
Austin, Texas, United States, 78705
GSK Investigational Site
Dallas, Texas, United States, 75246
GSK Investigational Site
Fort Worth, Texas, United States, 76104
GSK Investigational Site
Houston, Texas, United States, 77098
GSK Investigational Site
Houston, Texas, United States, 77027
GSK Investigational Site
Longview, Texas, United States, 75605
GSK Investigational Site
Tyler, Texas, United States, 75708
United States, Virginia
GSK Investigational Site
Hampton, Virginia, United States, 23666
United States, Washington
GSK Investigational Site
Seattle, Washington, United States, 98122
GSK Investigational Site
Spokane, Washington, United States, 99204
United States, Wisconsin
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00373945     History of Changes
Other Study ID Numbers: ABC107442, SHAPE
Study First Received: September 7, 2006
Last Updated: May 15, 2009
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:
Acquired Immunodeficiency Syndrome
HIV Infections
Hypersensitivity
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Abacavir
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014