HIV-infected PatientsPhase 2ABC-ASANCT03316534
Effect of Aspirin on Abacavir-induced Platelet Reactivity in HIV-infected Patients
A Phase 2 study testing Aspirin in people with HIV-infected Patients, run by Azienda Ospedaliera di Perugia.
Trial summary
The specific research questions addressed in the present study are: to investigate the impact of treatment with low-dose aspirin in HIV-1-infected patients treated with ABC and test it would result in decreased in vivo platelet activation and platelet hyperreactivity to investigate if aspirin has the same effects in… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV-infected Patients
- What is being tested?
- Aspirin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 2 Jan 2017to 12 Oct 2017
- Phase
- Phase 2
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- a viral load <50 copies per millilitre
- ABC treatment for at least 6 months
Who cannot join
- age younger than 18
- nonsteroidal anti-inflammatory drug use in the past week (including aspirin), renal failure (creatinine clearance <30 mL/min), platelet count <100,000/microL, history of gastrointestinal bleeding within the last 6 months, presence of coexisting inflammatory disease, cancer, active bacterial or fungal infection, bleeding history, oral anticoagulant therapy and allergy to aspirin
About this study
The specific research questions addressed in the present study are:
- to investigate the impact of treatment with low-dose aspirin in HIV-1-infected patients treated with ABC and test it would result in decreased in vivo platelet activation and platelet hyperreactivity
- to investigate if aspirin has the same effects in HIV-infected as in HIV-uninfected patients.
Read the detailed description
Highly active antiretroviral therapy (HAART) may reduce the deleterious effects of HIV on the cardiovascular system by decreasing viral load and chronic inflammation; however some antiretrovirals enhance cardiovascular risk due to direct adverse effects on platelets or the endothelium.
Abacavir/lamivudine (ABC/3TC) and tenofovir/emtricitabine (TDF/FTC) are the most widely used nucleoside reverse transcriptase inhibitor (NRTI) associations in HAART. ABC has been initially considered as one of the most benign antiretroviral drugs due to a better metabolic profile than other nucleoside analogues, but since the D.A.D. study reported an association between the use of ABC and an increase in cardiovascular risk there has been controversy around this drug.
Clinical evidence suggests that in vivo platelet activation and platelet hyperreactivity contribute to adverse cardiovascular events and hyperreactive platelets may transform a normal reparative response to a mild arterial injury into an unwanted thrombotic event.
Aspirin is the cornerstone in the prevention of atherothrombotic events, as it has been shown to be effective both in the primary and secondary prevention of MI (6), and its beneficial effects likely involve the modulation of inflammatory and immune pathways. But despite heightened awareness regarding elevated CVD risk among HIV-infected patients, aspirin or others antiplatelet therapy were markedly underprescribed among HIV-infected patients at risk for CVD events (7).
Based on this, the proposed study will assess whether low-dose aspirin, in well-characterized HIV-1-infected patients treated with ABC, would result in decreased in vivo platelet activation and platelet hyperreactivity. Moreover will be investigate if aspirin will have the same effects in HIV-infected as in HIV-uninfected patients.
- Conditions
- HIV-infected Patients
- Being tested
- Aspirin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
Aspirin (100 mg once a day)
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Drug: Aspirin |
| Aspirin | Active comparator | Aspirin (100 mg/daily) Receives: Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet reactivity
PFA-100® collagen/epinephrine (C/EPI) cartridge closure time; light transmission aggregometry induced by arachidonic acid (1mM), collagen (0.8, 1.2 and 2 microg/ml) and epinephrine (100 microM); PAC-1; soluble P-selectin; sCD40L; platelet microparticles detection and quantification.
Measured: Change from baseline at day 15 and at day 30.
Secondary outcomes (1)
Serum TxB2 levels and urinary 11-dehydro-TxB2 levels
Measured: Change from baseline at day 14 after aspirin intake.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study start2 Jan 2017
- Primary completion30 Apr 2017
- Study completion12 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-infected PatientsStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- HIV subjects (all on ABC therapy) who fulfilled thee admission criteria will be randomized to either of 2 groups (A or B) with 20 subjects each that received placebo or aspirin (100 mg/daily) for two weeks. At the end of the two week period (T15), patients of group A will be switched to placebo, while group B will be switched to aspirin for another 2 weeks (T30). Adherence will be confirmed by pill count at the end of each study period.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera di Perugia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Gresele, Azienda Ospedaliera di Perugia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03316534
- Sponsor's protocol ID
- 1452/13/ACC
- Acronym
- ABC-ASA
- Status last verified
- Oct 2017
- First submitted
- 12 Oct 2017
- Last updated
- 20 Oct 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aspirin on Abacavir-induced Platelet Reactivity in HIV-infected Patients
- ClinicalTrials.gov ID
- NCT03316534
- Acronym / sponsor ID
- ABC-ASA / 1452/13/ACC
- Conditions
- HIV-infected Patients
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Azienda Ospedaliera di PerugiaUniversity, hospital or other
- Study start
- 2 Jan 2017 (actual)
- Primary completion
- 30 Apr 2017 (actual)
- Study completion
- 12 Oct 2017 (actual)
- First posted
- 20 Oct 2017 (actual)
- 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.
The specific research questions addressed in the present study are:
- to investigate the impact of treatment with low-dose aspirin in HIV-1-infected patients treated with ABC and test it would result in decreased in vivo platelet activation and platelet hyperreactivity
- to investigate if aspirin has the same effects in HIV-infected as in HIV-uninfected patients.
Detailed description
Highly active antiretroviral therapy (HAART) may reduce the deleterious effects of HIV on the cardiovascular system by decreasing viral load and chronic inflammation; however some antiretrovirals enhance cardiovascular risk due to direct adverse effects on platelets or the endothelium.
Abacavir/lamivudine (ABC/3TC) and tenofovir/emtricitabine (TDF/FTC) are the most widely used nucleoside reverse transcriptase inhibitor (NRTI) associations in HAART. ABC has been initially considered as one of the most benign antiretroviral drugs due to a better metabolic profile than other nucleoside analogues, but since the D.A.D. study reported an association between the use of ABC and an increase in cardiovascular risk there has been controversy around this drug.
Clinical evidence suggests that in vivo platelet activation and platelet hyperreactivity contribute to adverse cardiovascular events and hyperreactive platelets may transform a normal reparative response to a mild arterial injury into an unwanted thrombotic event.
Aspirin is the cornerstone in the prevention of atherothrombotic events, as it has been shown to be effective both in the primary and secondary prevention of MI (6), and its beneficial effects likely involve the modulation of inflammatory and immune pathways. But despite heightened awareness regarding elevated CVD risk among HIV-infected patients, aspirin or others antiplatelet therapy were markedly underprescribed among HIV-infected patients at risk for CVD events (7).
Based on this, the proposed study will assess whether low-dose aspirin, in well-characterized HIV-1-infected patients treated with ABC, would result in decreased in vivo platelet activation and platelet hyperreactivity. Moreover will be investigate if aspirin will have the same effects in HIV-infected as in HIV-uninfected patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- HIV subjects (all on ABC therapy) who fulfilled thee admission criteria will be randomized to either of 2 groups (A or B) with 20 subjects each that received placebo or aspirin (100 mg/daily) for two weeks. At the end of the two week period (T15), patients of group A will be switched to placebo, while group B will be switched to aspirin for another 2 weeks (T30). Adherence will be confirmed by pill count at the end of each study period.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: AspirinPlacebo |
| Aspirin | Active comparator | Drug: AspirinAspirin (100 mg/daily) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- a viral load <50 copies per millilitre
- ABC treatment for at least 6 months
Key exclusion criteria (2 listed)
- age younger than 18
- nonsteroidal anti-inflammatory drug use in the past week (including aspirin), renal failure (creatinine clearance <30 mL/min), platelet count <100,000/microL, history of gastrointestinal bleeding within the last 6 months, presence of coexisting inflammatory disease, cancer, active bacterial or fungal infection, bleeding history, oral anticoagulant therapy and allergy to aspirin
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 |
|---|---|---|
| AspirinAspirin (100 mg once a day) | Drug | Aspirin, Placebo |
Primary outcome
Platelet reactivity
Time frame: Change from baseline at day 15 and at day 30.
PFA-100® collagen/epinephrine (C/EPI) cartridge closure time; light transmission aggregometry induced by arachidonic acid (1mM), collagen (0.8, 1.2 and 2 microg/ml) and epinephrine (100 microM); PAC-1; soluble P-selectin; sCD40L; platelet microparticles detection and quantification.
1 secondary outcome
Serum TxB2 levels and urinary 11-dehydro-TxB2 levels
Time frame: Change from baseline at day 14 after aspirin intake.
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 20 Oct 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aspirin in people with HIV-infected Patients, run by Azienda Ospedaliera di Perugia.
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 2 inclusion and 2 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 20 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Platelet reactivity (time frame: Change from baseline at day 15 and at day 30.). 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 20 Oct 2017; AzTrials last refreshed its copy on 8 Nov 2026.