HIVPhase 4NCT01813357
Does Rosuvastatin Delay Progression of Atherosclerosis in HIV
A Phase 4 study testing Rosuvastatin in people with HIV and Cardiovascular Disease, run by Bayside Health at 2 sites in 2 countries.
Trial summary
This study is a randomised double blind placebo controlled trial comparing Rosuvastatin with placebo in HIV positive people who are at intermediate cardiovascular risk. It is possible that HIV positive people will receive a greater benefit from statins because of their higher baseline levels of inflammation. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- HIV, Cardiovascular Disease
- What is being tested?
- Rosuvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 2 Jul 2013to 1 Nov 2018
- Phase
- Phase 4
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Moderate cardiovascular disease (CVD) risk, (10-15% 10 year risk of CVD)
- HIV positive
- Stable combination anti-retroviral therapy (cART) with plasma HIV viral load <200copies/ml for ≥ 6 months
Who cannot join
- Recommended use of lipid lowering therapy according to Australian guidelines
- Prior use of statin, fibrate, ezetimibe within the last six months
- Contraindication to statin use
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Does Rosuvastatin Delay Progression of Atherosclerosis in People With HIV Infection at Moderate Cardiovascular Risk? A Multicentre Randomized, Double Blind Placebo-controlled Trial
This study is a randomised double blind placebo controlled trial comparing Rosuvastatin with placebo in HIV positive people who are at intermediate cardiovascular risk.
It is possible that HIV positive people will receive a greater benefit from statins because of their higher baseline levels of inflammation. Current Australian guidelines recommend initiation of statin therapy on the basis of cholesterol level and the presence of other risk factors for heart disease (such as diabetes) but do not take into account whether a patient is infected with HIV. This study aims to determine what benefit HIV infected people will receive from starting statin therapy earlier then currently recommended.
Read the detailed description
Participants will be randomised to receive either the active agent (Rosuvastatin) or a placebo once daily for 96 weeks.
Participants will undergo blood tests and ultrasounds of the arteries of the neck (carotid intima media thickness) prior to starting Rosuvastatin and then after 1 and 2 years on the drug to determine what effect it has on markers of inflammation, cholesterol levels and thickness of blood vessels.
- Conditions
- HIV, Cardiovascular Disease
- Being tested
- Rosuvastatin, Placebo
- Keywords
- HIV, Cardiovascular disease, Inflammation, Statin
- Medical subject headings
- Cardiovascular Diseases, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
Also called Brand name: Crestor
encapsulated tablet 20mg daily
PlaceboOther
Also called Sugar Pill
Placebo arm included to maintain blinding
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | sugar pill that is encapsulated so as to appear identical to the active agent Receives: Other: Placebo |
| Rosuvastatin | Experimental | Rosuvastatin 20mg daily Receives: Drug: Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression of Carotid Intima Media Thickness
Carotid intima media thickness will be measured by ultrasonography and the change from baseline to week 96 calculated
Measured: Baseline to week 96
Secondary outcomes (1)
Rates of Adverse Events
Number of participants with adverse events in total and also the number of participants with adverse events thought secondary to the study medication
Measured: Will be assessed every 12 weeks and formally reported at 96 weeks of followup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2013 (estimated)
- Study start2 Jul 2013
- Primary completion17 May 2018
- Study completion1 Nov 2018
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 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayside Health
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Jennifer Hoy, Principal investigator, Alfred health, Monash University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01813357
- Sponsor's protocol ID
- AH-491/12
- Other IDs
- ACTRN12612001082897
- Status last verified
- Aug 2020
- First submitted
- 9 Dec 2012
- Last updated
- 28 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Trevillyan JM, Dart A, Paul E, Cavassini M, Fehr J, Staehelin C, Dewar EM, Hoy JF, Calmy A. Impact of rosuvastatin on atherosclerosis in people with HIV at moderate cardiovascular risk: a randomised, controlled trial. AIDS. 2021 Mar 15;35(4):619-624. doi: 10.1097/QAD.0000000000002764.
PubMed 33252480
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Rosuvastatin Delay Progression of Atherosclerosis in People With HIV Infection at Moderate Cardiovascular Risk? A Multicentre Randomized, Double Blind Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT01813357
- Acronym / sponsor ID
- AH-491/12
- Conditions
- HIV, Cardiovascular Disease
- Keywords
- HIV, Cardiovascular disease, Inflammation, Statin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Bayside HealthOther government
- Study start
- 2 Jul 2013 (actual)
- Primary completion
- 17 May 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 19 Mar 2013 (estimated)
- Results
- Posted 28 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a randomised double blind placebo controlled trial comparing Rosuvastatin with placebo in HIV positive people who are at intermediate cardiovascular risk.
It is possible that HIV positive people will receive a greater benefit from statins because of their higher baseline levels of inflammation. Current Australian guidelines recommend initiation of statin therapy on the basis of cholesterol level and the presence of other risk factors for heart disease (such as diabetes) but do not take into account whether a patient is infected with HIV. This study aims to determine what benefit HIV infected people will receive from starting statin therapy earlier then currently recommended.
Detailed description
Participants will be randomised to receive either the active agent (Rosuvastatin) or a placebo once daily for 96 weeks.
Participants will undergo blood tests and ultrasounds of the arteries of the neck (carotid intima media thickness) prior to starting Rosuvastatin and then after 1 and 2 years on the drug to determine what effect it has on markers of inflammation, cholesterol levels and thickness of blood vessels.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Placebosugar pill that is encapsulated so as to appear identical to the active agent |
| Rosuvastatin | Experimental | Drug: RosuvastatinRosuvastatin 20mg daily |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Moderate cardiovascular disease (CVD) risk, (10-15% 10 year risk of CVD)
- HIV positive
- Stable combination anti-retroviral therapy (cART) with plasma HIV viral load <200copies/ml for ≥ 6 months
Key exclusion criteria (3 listed)
- Recommended use of lipid lowering therapy according to Australian guidelines
- Prior use of statin, fibrate, ezetimibe within the last six months
- Contraindication to statin use
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 |
|---|---|---|
| RosuvastatinAlso: Brand name: Crestorencapsulated tablet 20mg daily | Drug | Rosuvastatin |
| PlaceboAlso: Sugar PillPlacebo arm included to maintain blinding | Other | Placebo |
Primary outcome
Progression of Carotid Intima Media Thickness
Time frame: Baseline to week 96
Carotid intima media thickness will be measured by ultrasonography and the change from baseline to week 96 calculated
1 secondary outcome
Rates of Adverse Events
Time frame: Will be assessed every 12 weeks and formally reported at 96 weeks of followup
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33252480Trevillyan JM, Dart A, Paul E, Cavassini M, Fehr J, Staehelin C, Dewar EM, Hoy JF, Calmy A. Impact of rosuvastatin on atherosclerosis in people with HIV at moderate cardiovascular risk: a randomised, controlled trial. AIDS. 2021 Mar 15;35(4):619-624. doi: 10.1097/QAD.0000000000002764.
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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 principal investigator
Alfred health, Monash University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rosuvastatin in people with HIV and Cardiovascular Disease, run by Bayside Health at 2 sites in 2 countries.
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 4 inclusion and 3 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 28 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia, Switzerland. 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 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?
Yes. Results are posted in the registry (first posted 28 Aug 2020). 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?
Progression of Carotid Intima Media Thickness (time frame: Baseline to week 96). 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 NCT01813357, 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 28 Aug 2020.