Clinical Utility Of Genetic Screening For HLA-B*5701, On Susceptibility To Abacavir Hypersensitivity
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|ClinicalTrials.gov Identifier: NCT00340080|
Recruitment Status : Completed
First Posted : June 21, 2006
Last Update Posted : January 25, 2010
|Condition or disease||Intervention/treatment||Phase|
|HIV Infection||Drug: Abacavir||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||1806 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase IV, Randomised, Multicentre, Double-blind, Study to Evaluate the Clinical Utility of Prospective Genetic Screening (HLA-B*5701) for Susceptibility to Abacavir Hypersensitivity|
|Study Start Date :||April 2006|
- Incidence of clinically-suspected ABC HSR during the 6-week observation period. Incidence of immunologically-confirmed ABC HSR. The clinical diagnosis of which occurs over the 6-week observation period.
- Incidence of clinically-suspected ABC HSR in Caucasians and in different ethnic sub-groups. Sensitivity and specificity, positive and negative predictive value of genetic screening for HLA-B*5701 for susceptibility of HSR.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00340080
|Study Director:||GSK Clinical Trials, MB BS MRCP FFPM||GlaxoSmithKline|