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| 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. |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Contacts and Locations
Hide Study 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 | |
| Los Angeles, California, United States, 90027 | |
| GSK Investigational Site | |
| Beverly Hills, California, United States, 90210 | |
| GSK Investigational Site | |
| Loma Linda, California, United States, 92357 | |
| GSK Investigational Site | |
| Tarzana, California, United States, 91356 | |
| GSK Investigational Site | |
| Newport Beach, California, United States, 92663 | |
| GSK Investigational Site | |
| Los Angeles, California, United States, 90069 | |
| GSK Investigational Site | |
| San Francisco, California, United States, 94115-1931 | |
| GSK Investigational Site | |
| Oakland, California, United States, 94609 | |
| 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 | |
| Hollywood, Florida, United States, 33020 | |
| GSK Investigational Site | |
| Orlando, Florida, United States, 32812 | |
| GSK Investigational Site | |
| Orlando, Florida, United States, 32803 | |
| GSK Investigational Site | |
| Fort Lauderdale, Florida, United States, 33308 | |
| United States, Georgia | |
| GSK Investigational Site | |
| Augusta, Georgia, United States, 30912 | |
| GSK Investigational Site | |
| Atlanta, Georgia, United States, 30308 | |
| GSK Investigational Site | |
| Atlanta, Georgia, United States, 30339 | |
| GSK Investigational Site | |
| Atlanta, Georgia, United States, 30309 | |
| 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 | |
| Baltimore, Maryland, United States, 21201 | |
| GSK Investigational Site | |
| Baltimore, Maryland, United States, 21229-5299 | |
| GSK Investigational Site | |
| Balitmore, Maryland, United States, 21287 | |
| 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, 63108 | |
| GSK Investigational Site | |
| St. Louis, Missouri, United States, 63110 | |
| United States, New York | |
| GSK Investigational Site | |
| New York, New York, United States, 10011 | |
| GSK Investigational Site | |
| Catskill, New York, United States, 12414 | |
| GSK Investigational Site | |
| Bronx, New York, United States, 10461 | |
| GSK Investigational Site | |
| Albany, New York, United States, 12208 | |
| 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 | |
| Greenville, North Carolina, United States, 27834 | |
| GSK Investigational Site | |
| Chapel Hill, North Carolina, United States, 27514 | |
| 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 | |
| Longview, Texas, United States, 75605 | |
| GSK Investigational Site | |
| Houston, Texas, United States, 77098 | |
| 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 | |
| Tyler, Texas, United States, 75708 | |
| GSK Investigational Site | |
| Houston, Texas, United States, 77027 | |
| United States, Virginia | |
| GSK Investigational Site | |
| Hampton, Virginia, United States, 23666 | |
| United States, Washington | |
| GSK Investigational Site | |
| Spokane, Washington, United States, 99204 | |
| GSK Investigational Site | |
| Seattle, Washington, United States, 98122 | |
| United States, Wisconsin | |
| GSK Investigational Site | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
More Information
| 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 |
|
HLA-B*5701 pharmacogenetic marker hypersensitivity to abacavir, retrospective analysis |
|
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 |
