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Predictors of Drug Hypersensitivity in HIV Infected Subjects

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ClinicalTrials.gov Identifier: NCT00168220
Recruitment Status : Withdrawn (Insufficient recruitment)
First Posted : September 15, 2005
Last Update Posted : January 20, 2012
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
HIV Infections Hypersensitivity

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
Actual Enrollment : 0 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Predictors of Drug Hypersensitivity in HIV Infected Subjects
Study Start Date : August 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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.


Outcome Measures

Biospecimen Retention:   Samples With DNA
plasma, DNA

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
HIV infection, exposed to antiretroviral treatment, either tolerant or hypersensitive to treatment
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00168220


Locations
Australia, Victoria
Alfred Hospital
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
The Alfred
National Health and Medical Research Council, Australia
Monash University
Investigators
Principal Investigator: Paul Cameron, Dr The Alfred
More Information

Responsible Party: Jennifer Hoy, Professor Jennifer Hoy, The Alfred
ClinicalTrials.gov Identifier: NCT00168220     History of Changes
Other Study ID Numbers: 113/05
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: January 20, 2012
Last Verified: January 2012

Keywords provided by Jennifer Hoy, The Alfred:
Treatment Experienced
HIV

Additional relevant MeSH terms:
HIV Infections
Hypersensitivity
Drug Hypersensitivity
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders