HIV InfectionPhase 2NCT00783614
Aspirin and Antiretroviral Therapy in HIV Infected Patients
A Phase 2 study testing Aspirin 325mg and Antiretroviral therapy (ART) in people with HIV Infection, run by Hennepin Healthcare Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to examine the effects of HIV treatment (antiretroviral therapy) and aspirin use on risk for cardiovascular disease among HIV infected persons. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- HIV Infection
- What is being tested?
- Aspirin 325mg and Antiretroviral therapy (ART)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Jun 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- HIV-infected (by positive HIV Ab or detectable HIV RNA level)
- No ART for at least previous 3 months
- Ready to start or re-start ART (regimen pre-chosen by patient and provider)
Who cannot join
- Age < 18 years, or >60 years
- Pregnancy
- Current aspirin use
- Presence of known atherosclerotic CVD determined by:
- Previous myocardial infarction
- Significant coronary atherosclerosis by angiography
Show all 17Show fewer
- Coronary revascularization procedure (coronary stent or surgical bypass)
- Previous cerebral vascular accident (stroke)
- Ischemic cardiomyopathy
- Carotid stenosis (>25% narrowing by carotid ultrasound)
- Aortic aneurysm
- Symptomatic peripheral vascular disease (claudication)
- Surgical revascularization procedure of peripheral vessels
- Hospitalization (within prior 2 weeks of study entry)
- Concurrent self-limited bacterial infections (does not include chronic viral infections)
- Clinical or pathologic diagnosis of systemic vasculitis
- Active drug or alcohol use
Trial locations and contacts
1 site in 1 country.
United States1 site
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
About this study
Official title: The Effect of Aspirin and Antiretroviral Therapy on Cardiovascular Risk in HIV Infected Patients: A Pilot Study
The purpose of this study is to examine the effects of HIV treatment (antiretroviral therapy) and aspirin use on risk for cardiovascular disease among HIV infected persons.
Read the detailed description
Cardiovascular disease is now a major health concern among persons with HIV infection. Our general hypothesis is that HIV-mediated inflammation and injury to vascular surfaces up-regulates thrombotic pathways and leads to damage of blood vessels that is promotes development of cardiovascular disease. HIV drug treatment (antiretroviral therapy; ART) may reduce inflammation and vessel injury via suppression of HIV replication, but also includes side effects or toxicity that may increase risk for cardiovascular disease in and of itself. In this context, additional anti-inflammatory and anti-thrombotic medications are needed. Acetylsalicylic acid (aspirin) is an excellent candidate and is commonly used for secondary prevention of cardiovascular events in the general population, but few studies have examined it's use in persons with HIV infection. The goal of this study is to generate pilot data regarding changes in measures of cardiovascular risk, as determined by reductions in inflammatory and thrombotic blood markers and a decrease in blood vessel injury (blood markers) and dysfunction (assessment of arterial elasticity), that occur after starting ART and aspirin among persons with HIV infection.
- Conditions
- HIV Infection
- Being tested
- Aspirin 325mg, Antiretroviral therapy (ART)
- Keywords
- HIV, Cardiovascular Disease, Endothelial Dysfunction
- Medical subject headings
- HIV Infections, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin 325mgDrug
Patients randomized to Aspirin 325mg po daily versus placebo pill daily
Antiretroviral therapy (ART)Drug
Patients randomized to start ART immediately or defer use for 1 month
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Start antiretroviral therapy (ART) immediately and initiate aspirin 325mg po daily Receives: Drug: Aspirin 325mg; Drug: Antiretroviral therapy (ART) |
| 2 | Placebo comparator | Start antiretroviral therapy (ART) immediately and initiate placebo pill daily Receives: Drug: Antiretroviral therapy (ART) |
| 3 | Active comparator | Defer antiretroviral therapy (ART) for 1 month and immediately initiate aspirin 325mg po daily Receives: Drug: Aspirin 325mg; Drug: Antiretroviral therapy (ART) |
| 4 | Placebo comparator | Defer antiretroviral therapy (ART) for 1 month and immediately initiate placebo pill daily Receives: Drug: Antiretroviral therapy (ART) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Side Effects (Self-report) Number of Participants With Adverse Events
At each visit participants were asked if they were experience side effects to study medications. They were also asked if any new events or symptoms occurred since the last visit, even if they did not suspect it was related to the study medication
Measured: 6 months
Blood Markers of Inflammation, Endothelial Injury, and Thrombosis
Measured: changes from baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2008 (estimated)
- Study startOct 2008
- Primary completionJan 2010
- Study completionJun 2010
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionStudies 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
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hennepin Healthcare Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jason V Baker, MD, MS, Principal investigator, University of Minnesota; HCMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00783614
- Sponsor's protocol ID
- PCC-002
- Status last verified
- Oct 2017
- First submitted
- 31 Oct 2008
- Last updated
- 21 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kunisaki KM, Quick H, Baker JV. HIV antiretroviral therapy reduces circulating surfactant protein-D levels. HIV Med. 2011 Oct;12(9):580-1. doi: 10.1111/j.1468-1293.2011.00920.x. No abstract available.
PubMed 21951596
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Aspirin and Antiretroviral Therapy on Cardiovascular Risk in HIV Infected Patients: A Pilot Study
- ClinicalTrials.gov ID
- NCT00783614
- Acronym / sponsor ID
- PCC-002
- Conditions
- HIV Infection
- Keywords
- HIV, Cardiovascular Disease, Endothelial Dysfunction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Hennepin Healthcare Research InstituteUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 3 Nov 2008 (estimated)
- Results
- Posted 17 Apr 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the effects of HIV treatment (antiretroviral therapy) and aspirin use on risk for cardiovascular disease among HIV infected persons.
Detailed description
Cardiovascular disease is now a major health concern among persons with HIV infection. Our general hypothesis is that HIV-mediated inflammation and injury to vascular surfaces up-regulates thrombotic pathways and leads to damage of blood vessels that is promotes development of cardiovascular disease. HIV drug treatment (antiretroviral therapy; ART) may reduce inflammation and vessel injury via suppression of HIV replication, but also includes side effects or toxicity that may increase risk for cardiovascular disease in and of itself. In this context, additional anti-inflammatory and anti-thrombotic medications are needed. Acetylsalicylic acid (aspirin) is an excellent candidate and is commonly used for secondary prevention of cardiovascular events in the general population, but few studies have examined it's use in persons with HIV infection. The goal of this study is to generate pilot data regarding changes in measures of cardiovascular risk, as determined by reductions in inflammatory and thrombotic blood markers and a decrease in blood vessel injury (blood markers) and dysfunction (assessment of arterial elasticity), that occur after starting ART and aspirin among persons with HIV infection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Aspirin 325mg, Drug: Antiretroviral therapy (ART)Start antiretroviral therapy (ART) immediately and initiate aspirin 325mg po daily |
| 2 | Placebo comparator | Drug: Antiretroviral therapy (ART)Start antiretroviral therapy (ART) immediately and initiate placebo pill daily |
| 3 | Active comparator | Drug: Aspirin 325mg, Drug: Antiretroviral therapy (ART)Defer antiretroviral therapy (ART) for 1 month and immediately initiate aspirin 325mg po daily |
| 4 | Placebo comparator | Drug: Antiretroviral therapy (ART)Defer antiretroviral therapy (ART) for 1 month and immediately initiate placebo pill daily |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- HIV-infected (by positive HIV Ab or detectable HIV RNA level)
- No ART for at least previous 3 months
- Ready to start or re-start ART (regimen pre-chosen by patient and provider)
Key exclusion criteria (17 listed)
- Age < 18 years, or >60 years
- Pregnancy
- Current aspirin use
- Presence of known atherosclerotic CVD determined by:
- Hospitalization (within prior 2 weeks of study entry)
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 |
|---|---|---|
| Aspirin 325mgPatients randomized to Aspirin 325mg po daily versus placebo pill daily | Drug | 1, 3 |
| Antiretroviral therapy (ART)Patients randomized to start ART immediately or defer use for 1 month | Drug | 1, 2, 3, 4 |
Primary outcome
Number of Participants With Side Effects (Self-report) Number of Participants With Adverse Events
Time frame: 6 months
At each visit participants were asked if they were experience side effects to study medications. They were also asked if any new events or symptoms occurred since the last visit, even if they did not suspect it was related to the study medication
Blood Markers of Inflammation, Endothelial Injury, and Thrombosis
Time frame: changes from baseline to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21951596Kunisaki KM, Quick H, Baker JV. HIV antiretroviral therapy reduces circulating surfactant protein-D levels. HIV Med. 2011 Oct;12(9):580-1. doi: 10.1111/j.1468-1293.2011.00920.x. No abstract available.
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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.
Jason V Baker, MD, MS principal investigator
University of Minnesota; HCMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aspirin 325mg and Antiretroviral therapy (ART) in people with HIV Infection, run by Hennepin Healthcare Research Institute at 1 site in United States.
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 3 inclusion and 17 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: stopped early, as of the sponsor's last update on 21 Nov 2017. 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 United States. 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. 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?
Yes. Results are posted in the registry (first posted 17 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Side Effects (Self-report) Number of Participants With Adverse Events (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00783614, which also lists 1 linked publication.
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 21 Nov 2017.