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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01886638
Registration number
NCT01886638
Ethics application status
Date submitted
24/06/2013
Date registered
26/06/2013
Date last updated
22/05/2015
Titles & IDs
Public title
Determining the Effect of Abacavir on Platelet Activation
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Scientific title
Determining the Effect of Abacavir on Platelet Activation in Virologically Suppressed HIV Positive Men: an Open Label Interventional Study
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Secondary ID [1]
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ACTRN12613000570785
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Secondary ID [2]
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248-13
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
HIV
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Cardiovascular Disease
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Experimental: Abacavir - Abacavir 600mg (as two 300mg tablets) once daily for 15 days
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in Phosphorylated Vasodilator Stimulated Phosphoprotein (P-VASP) assay
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Assessment method [1]
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Timepoint [1]
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Baseline, day 15 and day 48
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Secondary outcome [1]
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Platelet aggregation
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Assessment method [1]
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Measurement of the degree of platelet aggregation in response to collagen related peptide and thrombin receptor-agonist peptide
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Timepoint [1]
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Baseline, Day 15 and day 48
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Secondary outcome [2]
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Platelet specific collagen receptor glycoprotein VI (GPVI)
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Assessment method [2]
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Measurement of the expression and shedding of platelet specific collagen receptor GPVI
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Timepoint [2]
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Baseline, Day 15 and Day 48
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Eligibility
Key inclusion criteria
* > 18 years of age
* Male
* HIV positive
* Stable non-abacavir containing anti-retroviral regimen
* Undetectable HIV Viral load
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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Key exclusion criteria
* HLA-B*57*01 allele positivity
* Previous allergy to abacavir
* Known cardiovascular disease
* High Baseline cardiovascular risk (Framingham risk score > 20%)
* Current or recent antiplatelet therapy
* Pre-existing platelet or bleeding disorder (i.e. Thrombophilia, Thrombocytopenia, Von willebrands disease, Haemophilia)
* Significant Chronic liver disease
* Current Methadone use
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/10/2014
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Sample size
Target
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Accrual to date
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Final
23
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Alfred Health - Melbourne
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Funding & Sponsors
Primary sponsor type
Government body
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Name
Bayside Health
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
HIV positive patients have a two fold increased risk of developing cardiovascular disease (such as heart attacks and strokes). Cardiovascular disease appears to be due in part to both HIV and the side effects from anti-HIV medications. Abacavir (an important component of current HIV treatment regimens) is one medication shown to be associated with an increase the risk of heart attacks in some studies. The mechanism by which abacavir does this is unknown. We hypothesise that abacavir is leading to heart disease by interacting with platelets, which then form blood clots within the arteries supplying the heart, the subsequent blockage of the artery causing a heart attack. This study aims to determine if abacavir increases the activity (or "stickiness") of platelets, and thus provide evidence as to how it may be promoting heart attacks. It will consist of 23 HIV positive men who currently have well controlled HIV. Participants will take abacavir for 15 days in addition to their usual anti-HIV medications. A blood sample to assess platelet activity will be taken at baseline, following the 15 days of therapy (i.e. at the time of maximal abacavir effect) and again after a 28 day washout period (to determine if any effects are reversible).
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Trial website
https://clinicaltrials.gov/study/NCT01886638
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Jennifer Hoy, MBBS FRACP
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Address
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Alfred health, Monash University
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
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
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT01886638
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