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| Descriptive Information Fields | |||||
| Brief Title † | HLA-B*5701 And Hypersensitivity To Abacavir | ||||
| 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. | ||||
| 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. |
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| Detailed Description | |||||
| Study Phase | |||||
| Study Type † | Observational | ||||
| Study Design † | Retrospective | ||||
| Primary Outcome Measure † | |||||
| Secondary Outcome Measure † | |||||
| Condition † | HIV Infection | ||||
| Intervention † | Drug: Observational Study | ||||
| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | 280 | ||||
| Start Date † | August 2006 | ||||
| Completion Date | August 2007 | ||||
| Eligibility Criteria † | Inclusion criteria:
Exclusion criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00373945 | ||||
| Organization ID | ABC107442 | ||||
| Secondary IDs †† | SHAPE | ||||
| Study Sponsor † | GlaxoSmithKline | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | GlaxoSmithKline | ||||
| Verification Date | October 2008 | ||||
| First Received Date † | September 7, 2006 | ||||
| Last Updated Date | October 13, 2008 | ||||