Cardiovascular RiskCREATE1NCT01015092
Cardiovascular Risk Evaluation and Antiretrovirals in HIV
An observational study of Cardiovascular Risk and HIV Infections, run by King's College London at 1 site in United Kingdom.
Trial summary
The purpose of the study is to determine the main factors contributing to predicted 10 year cardiovascular risk in an HIV infected cohort, and the role of anti-HIV drug use in altering this risk Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Risk, HIV Infections
- How many people
- 1,024 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2005to Nov 2006
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: All HIV outpatients patients attending two London Hospitals
Who may be able to join
- Serologically proven HIV infection
- Attending general HIV outpatient clinic
Who cannot join
- Attending a specialist outpatient clinic which might lead to recruitment bias
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Guys & ST Thomas' Foundation Hospitals
London, SE30AA
About this study
Official title: Predicted 10-year Coronary Heart Disease Risk in HIV and Implications for Clinical Management: the CREATE Study
The purpose of the study is to determine the main factors contributing to predicted 10 year cardiovascular risk in an HIV infected cohort, and the role of anti-HIV drug use in altering this risk
- Conditions
- Cardiovascular Risk, HIV Infections
- Keywords
- HIV, Cardiovascular, Coronary hear disease, HAART, antiretroviral
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| unselected HIV outpatient attendees | All HIV patients attending for general HIV care at 2 London Hospitals |
What is being measured
The primary outcome is the main question the study is designed to answer.
10 year predicted cardiovascular risk
Measured: AT time of clinic attendence
Secondary outcomes (1)
coronary heart disease risk
Measured: at time of clinic attendence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2009 (estimated)
- Study startJun 2005
- Primary completionSep 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular RiskStudies of the same condition, open and under way.
- More trials run by King's College LondonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,024 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust
- Investigators
- Barry S Peters, MB BS. MD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01015092
- Sponsor's protocol ID
- 05/Q0702/156
- Acronym
- CREATE1
- Status last verified
- Nov 2009
- First submitted
- 16 Nov 2009
- Last updated
- 17 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicted 10-year Coronary Heart Disease Risk in HIV and Implications for Clinical Management: the CREATE Study
- ClinicalTrials.gov ID
- NCT01015092
- Acronym / sponsor ID
- CREATE1 / 05/Q0702/156
- Conditions
- Cardiovascular Risk, HIV Infections
- Keywords
- HIV, Cardiovascular, Coronary hear disease, HAART, antiretroviral
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,024 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust
- Study start
- Jun 2005
- Primary completion
- Sep 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 17 Nov 2009 (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.
The purpose of the study is to determine the main factors contributing to predicted 10 year cardiovascular risk in an HIV infected cohort, and the role of anti-HIV drug use in altering this risk
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| unselected HIV outpatient attendees | – | –All HIV patients attending for general HIV care at 2 London Hospitals |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All HIV outpatients patients attending two London Hospitals
Key inclusion criteria (2 listed)
- Serologically proven HIV infection
- Attending general HIV outpatient clinic
Key exclusion criteria (1 listed)
- Attending a specialist outpatient clinic which might lead to recruitment bias
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
10 year predicted cardiovascular risk
Time frame: AT time of clinic attendence
1 secondary outcome
coronary heart disease risk
Time frame: at time of clinic attendence
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 17 Nov 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.
Barry S Peters, MB BS. MD principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Risk and HIV Infections, run by King's College London at 1 site in United Kingdom.
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 1 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 17 Nov 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 United Kingdom. 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.
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?
10 year predicted cardiovascular risk (time frame: AT time of clinic attendence). 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 17 Nov 2009.