Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000570785
Ethics application status
Approved
Date submitted
18/05/2013
Date registered
20/05/2013
Date last updated
27/11/2018
Date data sharing statement initially provided
27/11/2018
Date results information initially provided
27/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Determining the Effect of Abacavir on Platelet Activation in HIV positive men
Scientific title
Determining the Effect in HIV positive men of Abacavir administration on markers of Platelet Activation
Secondary ID [1] 282525 0
None
Universal Trial Number (UTN)
U1111-1143-2410
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV 289187 0
Cadiovascular disease 289188 0
Condition category
Condition code
Infection 289510 289510 0 0
Acquired immune deficiency syndrome (AIDS / HIV)
Cardiovascular 289511 289511 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Abacavir 600mg (2x 300mg oral tablets) daily for 15 days.
Adherence assessed by compliance questionaire and tablet return at day 15 visit
Intervention code [1] 287184 0
Treatment: Drugs
Comparator / control treatment
No control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289611 0
Change in P-VASP assay
Timepoint [1] 289611 0
Day 15
Secondary outcome [1] 302855 0
Changes in novel markers of platelet activaiton (expression and shedding of platelet specific collagen receptor, GPVI)
Timepoint [1] 302855 0
day 15
Secondary outcome [2] 302856 0
Incidence of adverse events (specifically hypersensitivity reactions - assessed clinically)
Timepoint [2] 302856 0
Day 15 and 43
Secondary outcome [3] 302857 0
Reversibility of the effects of abacavir on platelet function, as assessed by changes in P-VASP assay and sGPVI.
Timepoint [3] 302857 0
at day 43 compared with baseline and day 15

Eligibility
Key inclusion criteria
HIV positive men with well controlled HIV (undetectable viral load for > six months) on a non-abacavir containing antiretroviral regimen
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Previous allergy to abacavir or HLA*B*57*01 positivity
High Cardiovascular risk
Platelet disorder
Current or recent use of antiplatelets

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This an open label single arm self-controlled interventional study
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
N/A
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The study is powered to demonstrate an effect of abacavir on platelet reactivity in HIV positive adult men. Conservatively assuming a mean 5% increase in platelet activation secondary to abacavir with a standard deviation of 5% (as was demonstrated by Satchell et.al.), we estimate that 23 participants are required to have an 80% power to detect a difference of one standard deviation in mean P-VASP between the baseline and day 15.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2013
Actual
1/08/2013
Date of last participant enrolment
Anticipated
31/12/2013
Actual
14/03/2014
Date of last data collection
Anticipated
Actual
1/07/2014
Sample size
Target
23
Accrual to date
Final
23
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 12559 0
The Alfred - Prahran
Recruitment postcode(s) [1] 24938 0
3004 - St Kilda Road Melbourne

Funding & Sponsors
Funding source category [1] 287305 0
Self funded/Unfunded
Name [1] 287305 0
Prof Jennifer Hoy
Country [1] 287305 0
Australia
Primary sponsor type
Hospital
Name
Alfred Health
Address
Alfred Health
Commercial Rd, Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 286057 0
None
Name [1] 286057 0
Address [1] 286057 0
Country [1] 286057 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289281 0
Alfred Health Ethics Commitee
Ethics committee address [1] 289281 0
C/O Alfred Health
Human research and Ethics
Commercial Rd
Melbourne VIC 3004
Ethics committee country [1] 289281 0
Australia
Date submitted for ethics approval [1] 289281 0
27/05/2013
Approval date [1] 289281 0
03/07/2013
Ethics approval number [1] 289281 0

Summary
Brief summary
open label single arm self-controlled trial of the affect of 15 days of abacavir on platelet function in healthy HIV positive volounteers
Trial website
Trial related presentations / publications
non currently
Public notes

Contacts
Principal investigator
Name 40154 0
Dr Janine Trevillyan
Address 40154 0
C/O Alfred Health
Department of Infectious Diseases
Commercial Rd
Melbourne VIC 3004
Country 40154 0
Australia
Phone 40154 0
+61 419743720
Fax 40154 0
Email 40154 0
[email protected]
Contact person for public queries
Name 40155 0
Dr Janine Trevillyan
Address 40155 0
C/O Alfred Health
Department of Infectious Diseases
Commercial Rd
Melbourne VIC 3004
Country 40155 0
Australia
Phone 40155 0
+61 419743720
Fax 40155 0
Email 40155 0
[email protected]
Contact person for scientific queries
Name 40156 0
Dr Janine Trevillyan
Address 40156 0
C/O Alfred Health
Department of Infectious Diseases
Commercial Rd
Melbourne VIC 3004
Country 40156 0
Australia
Phone 40156 0
+61 419743720
Fax 40156 0
Email 40156 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
The data from this small pilot study will not be shared


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.