Text Size

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This study has been withdrawn prior to enrollment.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:

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:
  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.
  Eligibility

Ages Eligible for Study:   18 Years and older
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
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

No publications provided

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
Acquired Immunodeficiency Syndrome
Drug Hypersensitivity
Hypersensitivity
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
 Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on May 21, 2013