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Predictors of Drug Hypersensitivity in HIV Infected Subjects
This study has been withdrawn prior to enrollment.
(Insufficient recruitment)
Sponsor:
The Alfred
Collaborators:
National Health and Medical Research Council, Australia
Monash University
Information provided by (Responsible Party):
Jennifer Hoy, The Alfred
ClinicalTrials.gov Identifier:
NCT00168220
First received: September 13, 2005
Last updated: January 19, 2012
Last verified: January 2012
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Purpose
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 |
|---|
| HIV Infections Hypersensitivity |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Retrospective |
| Official Title: | Predictors of Drug Hypersensitivity in HIV Infected Subjects |
Resource links provided by NLM:
Further study details as provided by Jennifer Hoy, The Alfred:
Biospecimen Retention: Samples With DNA
Detailed Description:
plasma, DNA
| Enrollment: | 0 |
| Study Start Date: | August 2005 |
| Groups/Cohorts |
|---|
|
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.
|
Detailed Description:
- To determine in a case control study clinical parameters associated with drug HSR to abacavir, nevirapine and efavirenz in HIV infected subjects.
- 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.
- 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.
- 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.
- 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.
Eligibility| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00168220
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
| Study First Received: | September 13, 2005 |
| Last Updated: | January 19, 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 |
ClinicalTrials.gov processed this record on June 22, 2017