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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Scientific title
Determining the Effect of Abacavir on Platelet Activation in Virologically Suppressed HIV Positive Men: an Open Label Interventional Study
Secondary ID [1] 0 0
ACTRN12613000570785
Secondary ID [2] 0 0
248-13
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV 0 0
Cardiovascular Disease 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Abacavir

Experimental: Abacavir - Abacavir 600mg (as two 300mg tablets) once daily for 15 days


Treatment: Drugs: Abacavir
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Phosphorylated Vasodilator Stimulated Phosphoprotein (P-VASP) assay
Timepoint [1] 0 0
Baseline, day 15 and day 48
Secondary outcome [1] 0 0
Platelet aggregation
Timepoint [1] 0 0
Baseline, Day 15 and day 48
Secondary outcome [2] 0 0
Platelet specific collagen receptor glycoprotein VI (GPVI)
Timepoint [2] 0 0
Baseline, Day 15 and Day 48

Eligibility
Key inclusion criteria
- > 18 years of age

- Male

- HIV positive

- Stable non-abacavir containing anti-retroviral regimen

- Undetectable HIV Viral load
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
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

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



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2014
Sample size
Target
Accrual to date
Final
23
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Health - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Bayside Health
Address
Country

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT01886638
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jennifer Hoy, MBBS FRACP
Address 0 0
Alfred health, Monash University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01886638