HLA-B*5701 And Hypersensitivity To Abacavir

Completed

Conditions studied: HIV Infection

In brief

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.

Key facts

Study ID

NCT00373945

Run by

GlaxoSmithKline

People needed

280

Starts

2006-08-01

Expected to finish

2007-08-01

Last updated by the study team

2009-05-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects with HIV-1 infection with clinically-suspected hypersensitivity to abacavir.
• Subjects must provide consent for skin patch testing and pharmacogenetic evaluation.

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Little Rock, Arkansas, United States
• GSK Investigational Site — Beverly Hills, California, United States
• GSK Investigational Site — Loma Linda, California, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Newport Beach, California, United States
• GSK Investigational Site — Oakland, California, United States
• GSK Investigational Site — San Francisco, California, United States
• GSK Investigational Site — Tarzana, California, United States
• GSK Investigational Site — Denver, Colorado, United States
• GSK Investigational Site — Denver, Colorado, United States
• GSK Investigational Site — Norwalk, Connecticut, United States
• GSK Investigational Site — Fort Lauderdale, Florida, United States
• GSK Investigational Site — Fort Lauderdale, Florida, United States
• GSK Investigational Site — Hollywood, Florida, United States
• GSK Investigational Site — Orlando, Florida, United States
• GSK Investigational Site — Orlando, Florida, 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 — Chicago, Illinois, United States
• GSK Investigational Site — Chicago, Illinois, United States
• GSK Investigational Site — Chicago, Illinois, United States
• GSK Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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