Clinical Trial: Predictors of Drug Hypersensitivity in HIV Infected Subjects

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Observational

Official Title: Predictors of Drug Hypersensitivity in HIV Infected Subjects

Brief Summary: 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.

Detailed Summary:

  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.

Sponsor: The Alfred

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: The Alfred

Dates:
Date Received: September 13, 2005
Date Started: August 2005
Date Completion:
Last Updated: January 19, 2012
Last Verified: January 2012