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WithdrawnNCT00168220

Predictors of Drug Hypersensitivity in HIV Infected Subjects

Status
Withdrawn
Phase
Study type
Observational
Enrollment
0 (actual)
Sponsor
The Alfred · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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 description

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.

Conditions

Timeline

Start date
2005-08-01
First posted
2005-09-15
Last updated
2012-01-20

Locations

1 site across 1 country: Australia

Source: ClinicalTrials.gov record NCT00168220. Inclusion in this directory is not an endorsement.

Predictors of Drug Hypersensitivity in HIV Infected Subjects (NCT00168220) · Clinical Trials Directory