Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000491662
Ethics application status
Approved
Date submitted
16/09/2005
Date registered
23/09/2005
Date last updated
21/06/2021
Date data sharing statement initially provided
21/06/2021
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
Secondary ID [1] 304546 0
Nil Known
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
No nevirapine
Control group
Historical

Outcomes
Primary outcome [1] 837 0
Identification of immunological factors increasing the risk of drug reactions
Timepoint [1] 837 0
N/A
Secondary outcome [1] 1654 0
N/A
Timepoint [1] 1654 0
No change

Eligibility
Key inclusion criteria
Treatment with the antiretroviral drugs Efavirenz, Nevirapine, or Abacavir.
Minimum age
18 Years
Maximum age
Not stated
Sex
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
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
3/08/2005
Actual
3/08/2005
Date of last participant enrolment
Anticipated
Actual
30/06/2008
Date of last data collection
Anticipated
Actual
30/06/2008
Sample size
Target
800
Accrual to date
Final
5
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 762 0
University
Name [1] 762 0
Monash University
Country [1] 762 0
Australia
Primary sponsor type
University
Name
Monash University , NHMRC (pending)
Address
Clayton Victoria Australia
Country
Australia
Secondary sponsor category [1] 309835 0
None
Name [1] 309835 0
None
Address [1] 309835 0
Mandatory field
Country [1] 309835 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2007 0
Alfred Hospital
Ethics committee address [1] 2007 0
85 Commercial Rd, Melbourne, Vic 3004
Ethics committee country [1] 2007 0
Australia
Date submitted for ethics approval [1] 2007 0
Approval date [1] 2007 0
16/06/2005
Ethics approval number [1] 2007 0

Summary
Brief summary
Drug hypersensitivity reactions mediated by T cells are increased in HIV infection and particular HLA types have been associated with reactions to the antiretroviral drugs Abacavir [HLA-B*5701] and Nevirapine [HLA-DRB1*0101]. B57 strongly predicts reactions with Abacavir probably via a direct effect of the drug on dendritic cell activation. Abacavir naïve subjects with B57 can also generate immunological response during in vitro culture suggesting a high precursor frequency for abacavir specific T cells responses. This project aims to determine how these drugs lead to hypersensitivity reactions and to define the genetic and immunological factors that can be used to predict reactions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35886 0
A/Prof Paul Cameron
Address 35886 0
85 Alfred Hospital, Melbourne, Victoria 3004, Australia
Country 35886 0
Australia
Phone 35886 0
+61 3 9076 2000
Fax 35886 0
Email 35886 0
[email protected]
Contact person for public queries
Name 9826 0
A/Prof 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
[email protected]
Contact person for scientific queries
Name 754 0
A/Prof 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
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.