Status:

COMPLETED

HLA-B*5701 And Hypersensitivity To Abacavir

Lead Sponsor:

GlaxoSmithKline

Conditions:

HIV Infection

Eligibility:

All Genders

18+ years

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 marke...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    August 1 2006

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ESTIMATED

    End Date :

    August 1 2007

    Estimated Enrollment :

    280 Patients enrolled

    Trial Details

    Trial ID

    NCT00373945

    Start Date

    August 1 2006

    End Date

    August 1 2007

    Last Update

    May 18 2009

    Active Locations (55)

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    Page 1 of 14 (55 locations)

    1

    GSK Investigational Site

    Birmingham, Alabama, United States, 35294

    2

    GSK Investigational Site

    Little Rock, Arkansas, United States, 72207

    3

    GSK Investigational Site

    Beverly Hills, California, United States, 90210

    4

    GSK Investigational Site

    Loma Linda, California, United States, 92357