HIV Infection Clinical Trial
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.
| Verified date | May 2009 |
| Source | GlaxoSmithKline |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 280 |
| Est. completion date | August 2007 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Time Perspective: Retrospective
| Country | Name | City | State |
|---|---|---|---|
| United States | GSK Investigational Site | Akron | Ohio |
| United States | GSK Investigational Site | Albany | New York |
| United States | GSK Investigational Site | Atlanta | Georgia |
| United States | GSK Investigational Site | Atlanta | Georgia |
| United States | GSK Investigational Site | Atlanta | Georgia |
| United States | GSK Investigational Site | Augusta | Georgia |
| United States | GSK Investigational Site | Austin | Texas |
| United States | GSK Investigational Site | Balitmore | Maryland |
| United States | GSK Investigational Site | Baltimore | Maryland |
| United States | GSK Investigational Site | Baltimore | Maryland |
| United States | GSK Investigational Site | Beverly Hills | California |
| United States | GSK Investigational Site | Birmingham | Alabama |
| United States | GSK Investigational Site | Bronx | New York |
| United States | GSK Investigational Site | Catskill | New York |
| United States | GSK Investigational Site | Chapel Hill | North Carolina |
| United States | GSK Investigational Site | Chicago | Illinois |
| United States | GSK Investigational Site | Chicago | Illinois |
| United States | GSK Investigational Site | Chicago | Illinois |
| United States | GSK Investigational Site | Dallas | Texas |
| United States | GSK Investigational Site | Denver | Colorado |
| United States | GSK Investigational Site | Denver | Colorado |
| United States | GSK Investigational Site | Detroit | Michigan |
| United States | GSK Investigational Site | Fort Lauderdale | Florida |
| United States | GSK Investigational Site | Fort Lauderdale | Florida |
| United States | GSK Investigational Site | Fort Worth | Texas |
| United States | GSK Investigational Site | Greenville | North Carolina |
| United States | GSK Investigational Site | Hampton | Virginia |
| United States | GSK Investigational Site | Hollywood | Florida |
| United States | GSK Investigational Site | Houston | Texas |
| United States | GSK Investigational Site | Houston | Texas |
| United States | GSK Investigational Site | Lexington | Kentucky |
| United States | GSK Investigational Site | Little Rock | Arkansas |
| United States | GSK Investigational Site | Loma Linda | California |
| United States | GSK Investigational Site | Longview | Texas |
| United States | GSK Investigational Site | Los Angeles | California |
| United States | GSK Investigational Site | Los Angeles | California |
| United States | GSK Investigational Site | Milwaukee | Wisconsin |
| United States | GSK Investigational Site | New York | New York |
| United States | GSK Investigational Site | Newport Beach | California |
| United States | GSK Investigational Site | Norwalk | Connecticut |
| United States | GSK Investigational Site | Oakland | California |
| United States | GSK Investigational Site | Orlando | Florida |
| United States | GSK Investigational Site | Orlando | Florida |
| United States | GSK Investigational Site | Philadelphia | Pennsylvania |
| United States | GSK Investigational Site | Portland | Oregon |
| United States | GSK Investigational Site | Rochester | New York |
| United States | GSK Investigational Site | San Francisco | California |
| United States | GSK Investigational Site | Seattle | Washington |
| United States | GSK Investigational Site | Spokane | Washington |
| United States | GSK Investigational Site | Springfield | Massachusetts |
| United States | GSK Investigational Site | St. Louis | Missouri |
| United States | GSK Investigational Site | St. Louis | Missouri |
| United States | GSK Investigational Site | Tarzana | California |
| United States | GSK Investigational Site | Tyler | Texas |
| United States | GSK Investigational Site | Valhalla | New York |
| Lead Sponsor | Collaborator |
|---|---|
| GlaxoSmithKline |
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