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.

Trial Profile

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.

Completed
Phase of Trial: Phase IV

Latest Information Update: 02 Feb 2010

At a glance

  • Drugs Abacavir (Primary)
  • Indications HIV infections; HIV-1 infections
  • Focus Adverse reactions; Pharmacogenomic
  • Acronyms PREDICT-1
  • Sponsors GlaxoSmithKline
  • Most Recent Events

    • 07 Jun 2017 Biomarkers information updated
    • 09 Oct 2008 Status changed from active, no longer recruiting to completed, as reported by ClinicalTrials.gov.
    • 24 Jul 2008 Based on data from this trial and the SHAPE study, the US FDA has requested information be added to the current Boxed Warning for abacavir or abacavir-containing treatments [published in an FDA media release].
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