NCT00168220

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

January 20, 2012

Status Verified

January 1, 2012

First QC Date

September 13, 2005

Last Update Submit

January 19, 2012

Conditions

HIV InfectionsHypersensitivity

Keywords

Treatment ExperiencedHIV

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

HIV infection, exposed to antiretroviral treatment, either tolerant or hypersensitive to treatment

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Biospecimen

Retention: SAMPLES WITH DNA

plasma, DNA

MeSH Terms

Conditions

HIV InfectionsHypersensitivity

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Paul Cameron, Dr

    The Alfred

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Jennifer Hoy

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

August 1, 2005

Last Updated

January 20, 2012

Record last verified: 2012-01

Locations

AU(1)