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Trial registered on ANZCTR


Registration number
ACTRN12605000491662
Ethics application status
Approved
Date submitted
16/09/2005
Date registered
23/09/2005
Date last updated
23/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Predictors of drug hypersensitivity in HIV infected subjects
Scientific title
Predictors of drug hypersensitivity in HIV infected subjects
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Drug hypersensitivity 613 0
Condition category
Condition code
Infection 686 686 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A case-control study to investigate hypersensitivie and tolerant individuals matched for HLA predispositions.
Intervention code [1] 637 0
None
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 837 0
Identification of immunological factors increasing the risk of drug reactions
Timepoint [1] 837 0
Secondary outcome [1] 1654 0
Timepoint [1] 1654 0

Eligibility
Key inclusion criteria
Treatment with the antiretroviral drugs Efavirenz, Nevirapine, or Abacavir.
Minimum age
18 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Case control
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 762 0
University
Name [1] 762 0
Monash University
Address [1] 762 0
Country [1] 762 0
Australia
Primary sponsor type
University
Name
Monash University , NHMRC (pending)
Address
Country
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2007 0
Alfred Hospital
Ethics committee address [1] 2007 0
Ethics committee country [1] 2007 0
Australia
Date submitted for ethics approval [1] 2007 0
Approval date [1] 2007 0
Ethics approval number [1] 2007 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35886 0
Address 35886 0
Country 35886 0
Phone 35886 0
Fax 35886 0
Email 35886 0
Contact person for public queries
Name 9826 0
Dr. Paul Cameron
Address 9826 0
Infectious Diseases Department
Alfred Hospital
Level 2 Burnet Building
Commercial Road
Prahran VIC 3004
Country 9826 0
Australia
Phone 9826 0
+61 3 92071449
Fax 9826 0
+61 3 92762431
Email 9826 0
Paul.Cameron@med.monash.edu.au
Contact person for scientific queries
Name 754 0
Dr. Paul Cameron
Address 754 0
Infectious Diseases Department
Alfred Hospital
Level 2 Burnet Building
Commercial Road
Prahran VIC 3004
Country 754 0
Australia
Phone 754 0
+61 3 92071449
Fax 754 0
+61 3 92762431
Email 754 0
Paul.Cameron@med.monash.edu.au

No information has been provided regarding IPD availability
Summary results
No Results