AtherosclerosisPhase 4NCT00673582
Effectiveness of Rosuvastatin at Preventing the Progression of Atherosclerosis in HIV Positive Patients
A Phase 4 study testing Rosuvastatin in people with Atherosclerosis and HIV Infections, run by University of British Columbia at 1 site in Canada.
Trial summary
Rosuvastatin is a drug used to lower cholesterol, which also has other cardiovascular benefits. The goal of this project is to determine if rosuvastatin is effective at slowing the development of heart disease in people with HIV. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Atherosclerosis, HIV Infections
- What is being tested?
- Rosuvastatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2008to Mar 2013
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV positive, at least one cardiovascular disease risk factor
Who cannot join
- Diabetes
- Previous vascular disease
- Muscular disease
- Current use of other lipid lowering therapy
Trial locations and contacts
1 site in 1 country.
Canada1 site
The St. Paul's Hospital HIV Metabolic Clinic & The BC Centre for Excellence in HIV/AIDS
Vancouver, British Columbia, V6Z 1Y6
About this study
Official title: Randomized, Multicentre, Double- Blind, Placebo Controlled Trial of Rosuvastatin 10 mg for Inhibition of Atherosclerosis Progression Assessed by Carotid Artery Ultrasound in HIV-positive Patients Treated With Antiretrovirals
Rosuvastatin is a drug used to lower cholesterol, which also has other cardiovascular benefits. The goal of this project is to determine if rosuvastatin is effective at slowing the development of heart disease in people with HIV. We expect that after 2 years of treatment people treated with rosuvastatin will show significantly better results than people treated with a placebo.
Read the detailed description
HIV+ patients with at least one cardiovascular risk factor will be randomized to either rosuvastatin 10mg/day or placebo for a period of 96 weeks. B-mode carotid ultrasound will assess the primary outcome measure of average total thickness (a composite measurement of intima media thickness and total plaque area) at baseline, 24, 48, 72 and 96 weeks. We hypothesize that rosuvastatin will be significantly more effective with respect to inhibition of change in average total thickness between baseline and 96 weeks compared to placebo.
- Conditions
- Atherosclerosis, HIV Infections
- Being tested
- Rosuvastatin, Placebo
- Keywords
- Statins, Intima Media Thickness, Plaque Area
- Medical subject headings
- Atherosclerosis, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
Also called Crestor
10 mg/day rosuvastatin
PlaceboDrug
Placebo, 10 mg a day for 96 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 10 mg/day rosuvastatin for 96 weeks Receives: Drug: Rosuvastatin |
| 2 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average total thickness (a composite of carotid intima media thickness and total plaque area)
Measured: 96 weeks
Secondary outcomes (1)
Carotid Intima Media Thickness, Total Plaque Area, Lipids
Measured: 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2008 (estimated)
- Study startApr 2008
- Primary completionDec 2012 (estimated)
- Study completionMar 2013 (estimated)
Why it stopped: Sponsor has withdrawn the funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca, CIHR Canadian HIV Trials Network
- Investigators
- Greg Bondy, MD, Principal investigator, University of British ColumbiaMarianne Harris, MD, Study director, University of British ColumbiaMarek Smeija, MD, Study director, University of British ColumbiaJoel Singer, MD, Study director, University of British ColumbiaG.B. John Mancini, MD, Study director, University of British ColumbiaSammy Chan, MD, Study director, University of British ColumbiaJulio Montaner, MD, Study director, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00673582
- Sponsor's protocol ID
- H07-00213
- Other IDs
- D3560L00059
- Status last verified
- Aug 2009
- First submitted
- 30 Apr 2008
- Last updated
- 25 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Multicentre, Double- Blind, Placebo Controlled Trial of Rosuvastatin 10 mg for Inhibition of Atherosclerosis Progression Assessed by Carotid Artery Ultrasound in HIV-positive Patients Treated With Antiretrovirals
- ClinicalTrials.gov ID
- NCT00673582
- Acronym / sponsor ID
- H07-00213
- Conditions
- Atherosclerosis, HIV Infections
- Keywords
- Statins, Intima Media Thickness, Plaque Area
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor has withdrawn the funding
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- AstraZeneca, CIHR Canadian HIV Trials Network
- Study start
- Apr 2008
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 7 May 2008 (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.
Rosuvastatin is a drug used to lower cholesterol, which also has other cardiovascular benefits. The goal of this project is to determine if rosuvastatin is effective at slowing the development of heart disease in people with HIV. We expect that after 2 years of treatment people treated with rosuvastatin will show significantly better results than people treated with a placebo.
Detailed description
HIV+ patients with at least one cardiovascular risk factor will be randomized to either rosuvastatin 10mg/day or placebo for a period of 96 weeks. B-mode carotid ultrasound will assess the primary outcome measure of average total thickness (a composite measurement of intima media thickness and total plaque area) at baseline, 24, 48, 72 and 96 weeks. We hypothesize that rosuvastatin will be significantly more effective with respect to inhibition of change in average total thickness between baseline and 96 weeks compared to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Rosuvastatin10 mg/day rosuvastatin for 96 weeks |
| 2 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- HIV positive, at least one cardiovascular disease risk factor
Key exclusion criteria (4 listed)
- Diabetes
- Previous vascular disease
- Muscular disease
- Current use of other lipid lowering 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 |
|---|---|---|
| RosuvastatinAlso: Crestor10 mg/day rosuvastatin | Drug | 1 |
| PlaceboPlacebo, 10 mg a day for 96 weeks | Drug | 2 |
Primary outcome
Average total thickness (a composite of carotid intima media thickness and total plaque area)
Time frame: 96 weeks
1 secondary outcome
Carotid Intima Media Thickness, Total Plaque Area, Lipids
Time frame: 96 weeks
Results and safety
The study was stopped early (reason given: Sponsor has withdrawn the funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2009.
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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.
Greg Bondy, MD principal investigator
University of British Columbia
Marianne Harris, MD study director
University of British Columbia
Marek Smeija, MD study director
University of British Columbia
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 Rosuvastatin in people with Atherosclerosis and HIV Infections, run by University of British Columbia at 1 site in Canada.
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 1 inclusion and 4 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 25 Aug 2009. 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 Canada. 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?
The study was stopped early (reason given: Sponsor has withdrawn the funding). Results are not available in the source record.
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?
Average total thickness (a composite of carotid intima media thickness and total plaque area) (time frame: 96 weeks). 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 25 Aug 2009.