HLA-B*5701 And Hypersensitivity To Abacavir
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.
2 other identifiers
observational
280
1 country
55
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2006
Shorter than P25 for all trials
55 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2006
CompletedFirst Submitted
Initial submission to the registry
September 7, 2006
CompletedFirst Posted
Study publicly available on registry
September 8, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2007
CompletedMay 18, 2009
May 1, 2009
September 7, 2006
May 15, 2009
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Subjects with HIV-1 infection with clinically-suspected hypersensitivity to abacavir.
- Subjects must provide consent for skin patch testing and pharmacogenetic evaluation.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (55)
GSK Investigational Site
Birmingham, Alabama, 35294, United States
GSK Investigational Site
Little Rock, Arkansas, 72207, United States
GSK Investigational Site
Beverly Hills, California, 90210, United States
GSK Investigational Site
Loma Linda, California, 92357, United States
GSK Investigational Site
Los Angeles, California, 90027, United States
GSK Investigational Site
Los Angeles, California, 90069, United States
GSK Investigational Site
Newport Beach, California, 92663, United States
GSK Investigational Site
Oakland, California, 94609, United States
GSK Investigational Site
San Francisco, California, 94115-1931, United States
GSK Investigational Site
Tarzana, California, 91356, United States
GSK Investigational Site
Denver, Colorado, 80204, United States
GSK Investigational Site
Denver, Colorado, 80220, United States
GSK Investigational Site
Norwalk, Connecticut, 06851, United States
GSK Investigational Site
Fort Lauderdale, Florida, 33308, United States
GSK Investigational Site
Fort Lauderdale, Florida, 33316, United States
GSK Investigational Site
Hollywood, Florida, 33020, United States
GSK Investigational Site
Orlando, Florida, 32803, United States
GSK Investigational Site
Orlando, Florida, 32812, United States
GSK Investigational Site
Atlanta, Georgia, 30308, United States
GSK Investigational Site
Atlanta, Georgia, 30309, United States
GSK Investigational Site
Atlanta, Georgia, 30339, United States
GSK Investigational Site
Augusta, Georgia, 30912, United States
GSK Investigational Site
Chicago, Illinois, 60612, United States
GSK Investigational Site
Chicago, Illinois, 60637, United States
GSK Investigational Site
Chicago, Illinois, 60657, United States
GSK Investigational Site
Lexington, Kentucky, 40536, United States
GSK Investigational Site
Balitmore, Maryland, 21287, United States
GSK Investigational Site
Baltimore, Maryland, 21201, United States
GSK Investigational Site
Baltimore, Maryland, 21229-5299, United States
GSK Investigational Site
Springfield, Massachusetts, 01107, United States
GSK Investigational Site
Detroit, Michigan, 48201, United States
GSK Investigational Site
St Louis, Missouri, 63108, United States
GSK Investigational Site
St Louis, Missouri, 63110, United States
GSK Investigational Site
Albany, New York, 12208, United States
GSK Investigational Site
Catskill, New York, 12414, United States
GSK Investigational Site
New York, New York, 10011, United States
GSK Investigational Site
Rochester, New York, 14604, United States
GSK Investigational Site
The Bronx, New York, 10461, United States
GSK Investigational Site
Valhalla, New York, 10595, United States
GSK Investigational Site
Chapel Hill, North Carolina, 27514, United States
GSK Investigational Site
Greenville, North Carolina, 27834, United States
GSK Investigational Site
Akron, Ohio, 44304, United States
GSK Investigational Site
Portland, Oregon, 97227, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19107, United States
GSK Investigational Site
Austin, Texas, 78705, United States
GSK Investigational Site
Dallas, Texas, 75246, United States
GSK Investigational Site
Fort Worth, Texas, 76104, United States
GSK Investigational Site
Houston, Texas, 77027, United States
GSK Investigational Site
Houston, Texas, 77098, United States
GSK Investigational Site
Longview, Texas, 75605, United States
GSK Investigational Site
Tyler, Texas, 75708, United States
GSK Investigational Site
Hampton, Virginia, 23666, United States
GSK Investigational Site
Seattle, Washington, 98122, United States
GSK Investigational Site
Spokane, Washington, 99204, United States
GSK Investigational Site
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials, MD
GlaxoSmithKline
Study Design
- Study Type
- observational
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 7, 2006
First Posted
September 8, 2006
Study Start
August 1, 2006
Study Completion
August 1, 2007
Last Updated
May 18, 2009
Record last verified: 2009-05