Predictors of Drug Hypersensitivity in HIV Infected Subjects

This study has been withdrawn prior to enrollment.

(Insufficient recruitment)

Sponsor:

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

History of Changes

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:

MedlinePlus related topics: Allergy Drug Reactions HIV/AIDS

U.S. FDA Resources

Further study details as provided by The Alfred:

Biospecimen Retention: Samples With DNA

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)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Health Authority:	Australia: National Health and Medical Research Council

Keywords provided by 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 September 27, 2016

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