HIVPhase 4NCT01886638
Determining the Effect of Abacavir on Platelet Activation
A Phase 4 study testing Abacavir in people with HIV and Cardiovascular Disease, run by Bayside Health at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- HIV, Cardiovascular Disease
- What is being tested?
- Abacavir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteAustralia
- Study dates
- Aug 2013to Oct 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 18 years of age
- Male
- HIV positive
- Stable non-abacavir containing anti-retroviral regimen
- Undetectable HIV Viral load
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determining the Effect of Abacavir on Platelet Activation in Virologically Suppressed HIV Positive Men: an Open Label Interventional Study
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.
Read more
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).
- Conditions
- HIV, Cardiovascular Disease
- Being tested
- Abacavir
- Keywords
- Platelets, HIV, Cardiovascular disease, Acute myocardial infarction, Abacavir, Antiretrovirals
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbacavirDrug
Also called Ziagen
| Study group | Role | What they receive |
|---|---|---|
| Abacavir | Experimental | Abacavir 600mg (as two 300mg tablets) once daily for 15 days Receives: Drug: Abacavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Phosphorylated Vasodilator Stimulated Phosphoprotein (P-VASP) assay
Measured: Baseline, day 15 and day 48
Secondary outcomes (2)
Platelet aggregation
Measurement of the degree of platelet aggregation in response to collagen related peptide and thrombin receptor-agonist peptide
Measured: Baseline, Day 15 and day 48
Platelet specific collagen receptor glycoprotein VI (GPVI)
Measurement of the expression and shedding of platelet specific collagen receptor GPVI
Measured: Baseline, Day 15 and Day 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2013 (estimated)
- Study startAug 2013
- Primary completionJun 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayside Health
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Jennifer Hoy, MBBS FRACP, Principal investigator, Alfred health, Monash UniversityJanine Trevillyan, MBBS FRACP, Principal investigator, Alfred Health, Monash university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01886638
- Sponsor's protocol ID
- 248-13
- Other IDs
- ACTRN12613000570785
- Status last verified
- May 2015
- First submitted
- 24 Jun 2013
- Last updated
- 22 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Effect of Abacavir on Platelet Activation in Virologically Suppressed HIV Positive Men: an Open Label Interventional Study
- ClinicalTrials.gov ID
- NCT01886638
- Acronym / sponsor ID
- 248-13
- Conditions
- HIV, Cardiovascular Disease
- Keywords
- Platelets, HIV, Cardiovascular disease, Acute myocardial infarction, Abacavir, Antiretrovirals
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Bayside HealthOther government
- Study start
- Aug 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 26 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abacavir | Experimental | Drug: AbacavirAbacavir 600mg (as two 300mg tablets) once daily for 15 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- > 18 years of age
- Male
- HIV positive
- Stable non-abacavir containing anti-retroviral regimen
- Undetectable HIV Viral load
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AbacavirAlso: Ziagen | Drug | Abacavir |
Primary outcome
Change in Phosphorylated Vasodilator Stimulated Phosphoprotein (P-VASP) assay
Time frame: Baseline, day 15 and day 48
2 secondary outcomes
Platelet aggregation
Time frame: Baseline, Day 15 and day 48
Platelet specific collagen receptor glycoprotein VI (GPVI)
Time frame: Baseline, Day 15 and Day 48
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Hoy, MBBS FRACP principal investigator
Alfred health, Monash University
Janine Trevillyan, MBBS FRACP principal investigator
Alfred Health, Monash university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Abacavir in people with HIV and Cardiovascular Disease, run by Bayside Health at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Phosphorylated Vasodilator Stimulated Phosphoprotein (P-VASP) assay (time frame: Baseline, day 15 and day 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2015.