Predictors of Drug Hypersensitivity in HIV Infected Subjects

This study has been withdrawn prior to enrollment.
(Insufficient recruitment)
Sponsor:
Collaborators:
National Health and Medical Research Council, Australia
Monash University
Information provided by (Responsible Party):
Jennifer Hoy, The Alfred
ClinicalTrials.gov Identifier:
NCT00168220
First received: September 13, 2005
Last updated: January 19, 2012
Last verified: January 2012

September 13, 2005
January 19, 2012
August 2005
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Complete list of historical versions of study NCT00168220 on ClinicalTrials.gov Archive Site
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Predictors of Drug Hypersensitivity in HIV Infected Subjects
Predictors of Drug Hypersensitivity in HIV Infected Subjects

A case-control study to look at hypersensitive and tolerant individuals matched for HLA genetic predisposition, when considering predictors of drug hypersensitivity.The study aims to identify the immunological factors increasing the risk of drug reactions in HIV positive individuals.

  1. To determine in a case control study clinical parameters associated with drug HSR to abacavir, nevirapine and efavirenz in HIV infected subjects.
  2. To measure functional and numerical differences in DC populations and responses to TLR ligands in patients with HSR and tolerant subjects sharing genetic markers for susceptibility to HSR.
  3. Identify the role of different DC populations in the development of abacavir reaction by mixing and depletion studies in sensitized subjects and in in vitro assays for abacavir hypersensitivity.
  4. To measure T cell parameters including T cell viability in culture, and expression of fas and fasL on blood mononuclear cells in HIV infected controls and HSR patients.
  5. To measure blood T cell populations including drug reactive T cells and T regulatory cells in tolerant and reactive subjects with genetic susceptibility to Abacavir and Nevirapine HSR.
Observational
Observational Model: Case Control
Time Perspective: Retrospective
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Retention:   Samples With DNA
Description:

plasma, DNA

Non-Probability Sample

HIV infection, exposed to antiretroviral treatment, either tolerant or hypersensitive to treatment

  • HIV Infections
  • Hypersensitivity
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  • Drug hypersensitive group
    HIV positive patients with a history of a Hypersensitivity Reaction to the antiretroviral medications Nevirapine, Abacavir or Efavirenz
  • Drug tolerant group
    HIV positive patients selected based on drug exposure greater than 2 weeks and tolerance to to Abacavir or Nevirapine.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
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Inclusion Criteria:

  • HIV infected patients on treatment with the drugs Efavirenz, Nevirapine, or Abacavir.
  • Age over 18 Cases are those who have had a hypersensitivity reaction, and controls are those who have had no reaction
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00168220
113/05
No
Jennifer Hoy, The Alfred
The Alfred
  • National Health and Medical Research Council, Australia
  • Monash University
Principal Investigator: Paul Cameron, Dr The Alfred
The Alfred
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP