Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000030471
Ethics application status
Not yet submitted
Date submitted
22/12/2006
Date registered
11/01/2007
Date last updated
11/01/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Identification of Susceptibility to Abacavir Hypersensitivity Reaction (HSR) in HIV-1 Infected Patients in Sydney, Australia and Development of Mechanisms for Risk Reduction
Scientific title
Identification of Susceptibility to Abacavir Hypersensitivity Reaction (HSR) in HIV-1 Infected Patients in Sydney, Australia and Development of Mechanisms for Risk Reduction
Secondary ID [1] 327 0
Holdsworth House Medical Practice: ABV-HSR-01
Universal Trial Number (UTN)
Trial acronym
Abacavir Hypersensitivity Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Human Immunodeficiency Virus Type-1 (HIV-1) 1528 0
Condition category
Condition code
Infection 1624 1624 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
Testing
• Strategy: sequence-specific primer (SSP) - amplify only intron 2 and exon 3 of a limited subset of HLA types
• 5’ primer in intron 2 hybridises to all B*57 and B*58 sequences but not others
• 3’ primer is a universal HLA-B primer
• If Polymerase chain reaction (PCR) negative: then not HLA-B*5701
• If PCR positive: then possibly HLA-B*57
– sequence PCR amplicon to distinguish HLA-B*57from HLA-B*58
– Use Single Nucleotide Polymorphism (SNPs) to determine HLA-B*5701 (or 06 or 08) or not
– Can distinguish these alleles from other HLA-B*57alleles and from HLA-B*58

Condition being observed
1. Prevalence of HLA-B*5701 in abacavir-naïve HIV-1 participants
2. Prevalence of HLA-B*5701 in abacavir-experienced participants who has also had abacavir HSR


Duration of the Trial
January to June 2007

No. HLA-B*5701 is a specific DNA sequence present in a small percentage of the total population. This sequence is part of the immune system and is associated with hypersensitivity reaction when given the HIV drug treatment abacavir.
Intervention code [1] 1526 0
Early detection / Screening
Comparator / control treatment
No comparator.
Control group

Outcomes
Primary outcome [1] 2241 0
To determine the prevalence of HLA-B*5701 in a cohort of HIV-1 infected patients attending a high HIV-caseload primary care practice in Sydney, Australia

Effectively two visits in total:
Visit Number Visit Name Visit Length
Visit 1/Day 0 Baseline 30 min
Visit 2/Day 14 Result Visit 15 min

Baseline Visit 1 (Day 0, 30 min)
All patients agreeing to participate will be consented using HREC approved consent form. Consent will be taken for:
1. Participation in the HLA-B*5701 prevalence study, with separate consent for
2. Development of a model recording of results in patient records and abacavir HSR registry.

A 9ml EDTA sample collected from participants (with the exception of STEAL participants). The samples will be sent for laboratory testing in a de-identified manner with first 2 letters of patient name and surname and date of birth.

All prospective laboratory samples will be processed by Centre for Immunology, St Vincent’s Hospital, Victoria Street, Darlinghurst, NSW 2010 (NATA/RCPA accredited)

Result Visit 2 (Day 14, 15 min)
All study participants will have an appointment return for consultation with their treating doctor to discuss their HLA-B*5701 results and the implications. Those testing positive for HLA-B*5701 will be advised not to commence abacavir in their future treatment regimen.

HLA-*B5701 results will be entered into patient medical records for future access.

Those participants consenting will have results entered into created model Registry.
Timepoint [1] 2241 0
At visit 1 (Day 0) and visit 2 (Day 14)
Secondary outcome [1] 3909 0
1. To determine the prevalence of HLA-B*5701 in patients with a clinical diagnosis of abacavir HSR attending a high HIV caseload primary care practice in Sydney (approximately 35) 35 cases (patients).
Timepoint [1] 3909 0
Measured at baseline
Secondary outcome [2] 3910 0
2. To develop a model for advising patients of testing results and recording the results in patient records.
Timepoint [2] 3910 0
Within 3 months of enrollment
Secondary outcome [3] 3911 0
3. To develop a model for a secure web based registry of patient B*5701 and abacavir HSR for use by treating physicians as a model for application in Australia and elsewhere.
Timepoint [3] 3911 0
Within 3 months of enrollment

Eligibility
Key inclusion criteria
1. Documented HIV-1 infection. 2. Abacavir treatment naive or 3. Previous abacavir HSR. 4. Able to understand and willing to sign informed consent. 5. Able to return for discussion of B*5701 test results.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Previous abacavir exposure with no diagnosis of abacavir HSR 2. Patients unable to submit a blood sample 3. Unable to understand English where translator not available.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1771 0
Commercial sector/Industry
Name [1] 1771 0
GlaxoSmithKline Australia
Country [1] 1771 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Holdsworth House Medical Practice
Address
Country
Australia
Secondary sponsor category [1] 1576 0
Commercial sector/Industry
Name [1] 1576 0
GlaxoSmithKline Australia
Address [1] 1576 0
Country [1] 1576 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 3315 0
Holdsworth House Medical Practice
Ethics committee address [1] 3315 0
Ethics committee country [1] 3315 0
Australia
Date submitted for ethics approval [1] 3315 0
Approval date [1] 3315 0
Ethics approval number [1] 3315 0

Summary
Brief summary
This study is being conducted in order to determine the proportion of HIV-1 patients attending Holdsworth House Medical Practice that may be susceptible to abacavir hypersensitivity reaction (HSR), which is associated with a genetic marker HLA-B*5701.
Abacavir is a drug used in combination with other antiviral drugs, which is helpful in treating HIV infection. Abacavir is generally well tolerated, but 5-8% of patients develop an allergic reaction to the drug and the allergic reaction is much more common in those patients who have the genetic marker HLA-B*5701. Abacavir HSR is an allergic reaction characterised by respiratory and gastrointestinal symptoms that may be life threatening if abacavir dosing continues. Thus avoiding the use of abacavir in patients carrying this genetic marker will reduce the likelihood of developing a potentially serious allergic reaction.
The study also aims to set up a model for a Registry where patient HLA-B*5701 results can be entered and made available to doctors who are licensed to prescribe HIV therapies in Australia via a secure password protected system. Ideally the Registry will be web-based, but if this is not feasible, it will be paper-based and managed by a recognised independent body already involved in the HIV field.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27460 0
Address 27460 0
Country 27460 0
Phone 27460 0
Fax 27460 0
Email 27460 0
Contact person for public queries
Name 10715 0
Dr Mark Bloch
Address 10715 0
Holdsworth House Medical Practice
Suite 1 32A Oxford Street
Darlinghurst NSW 2010
Country 10715 0
Australia
Phone 10715 0
+61 2 93317228
Fax 10715 0
+61 2 93315705
Email 10715 0
[email protected]
Contact person for scientific queries
Name 1643 0
Dr Mark Bloch
Address 1643 0
Holdsworth House Medical Practice
Suite 1 32A Oxford Street
Darlinghurst NSW 2010
Country 1643 0
Australia
Phone 1643 0
+61 2 93317228
Fax 1643 0
+61 2 93315705
Email 1643 0
[email protected]

No information has been provided regarding IPD availability


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.