Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT00168220
NCT00168220WithdrawnNot Applicable

Predictors of Drug Hypersensitivity in HIV Infected Subjects

The Alfred1 site in 1 countryStarted: August 2005Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Sponsor
Locations
1
Study OverviewStudy DesignEligibility CriteriaInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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

Exclusion Criteria

  • Not provided

Investigators

Sponsor
The Alfred
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jennifer Hoy

Professor Jennifer Hoy

The Alfred

Study Sites (1)

Loading locations...

Similar Trials

Terminated
Not Applicable
Predictors of drug hypersensitivity in HIV infected subjectsDrug hypersensitivityInfection - Acquired immune deficiency syndrome (AIDS / HIV)
ACTRN12605000491662Monash University , NHMRC (pending)5
Completed
Phase 1
A Phase I/II Study of Delayed-Type Hypersensitivity (DTH) Reactions to Intradermal HIV Envelope AntigenHIV Infections
NCT00000782National Institute of Allergy and Infectious Diseases (NIAID)50
Completed
Not Applicable
HIV-1 Subtype-specific Drug Resistance in Patients Failing Dolutegravir (DTG) Based RegimenHiv
NCT06285110University of Bern1,103
Completed
Phase 2
Using Drug Levels and Drug Resistance Testing to Select Effective Anti-HIV Drug Combinations in Patients With Drug-resistant HIVHIV Infections
NCT00027339National Institute of Allergy and Infectious Diseases (NIAID)53
Unknown
Not Applicable
Immunologic Control of Drug Resistant HIVHIV Infections
NCT00053404National Institute of Allergy and Infectious Diseases (NIAID)50