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Predictors of Drug Hypersensitivity in HIV Infected Subjects

Predictors of Drug Hypersensitivity in HIV Infected Subjects

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00168220
Enrollment
0
Registered
2005-09-15
Start date
2005-08-31
Completion date
Unknown
Last updated
2012-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections, Hypersensitivity

Keywords

Treatment Experienced, HIV

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 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.

Interventions

None listed

Sponsors

National Health and Medical Research Council, Australia
CollaboratorOTHER
Monash University
CollaboratorOTHER
The Alfred
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026