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HLA-B*5701 And Hypersensitivity To Abacavir

NCT00373945 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 280

Last updated 2009-05-18

No results posted yet for this study

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.

Conditions

  • HIV Infection

Interventions

DRUG

Observational Study

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials, MD · GlaxoSmithKline

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-31
Completion
2007-08-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00373945 on ClinicalTrials.gov