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| ID | Type | Description | Link |
|---|---|---|---|
| SHAPE |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational Study | Drug |
Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials, MD | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Birmingham | Alabama | 35294 | United States | ||
| GSK Investigational Site |
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| 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 |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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