- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01015092
Cardiovascular Risk Evaluation and Antiretrovirals in HIV (CREATE1)
November 16, 2009 updated by: King's College London
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
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
1024
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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London, United Kingdom, SE30AA
- Guys & ST Thomas' Foundation Hospitals
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
All HIV outpatients patients attending two London Hospitals
Description
Inclusion Criteria:
- Serologically proven HIV infection
- Attending general HIV outpatient clinic
Exclusion Criteria:
- Attending a specialist outpatient clinic which might lead to recruitment bias
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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unselected HIV outpatient attendees
All HIV patients attending for general HIV care at 2 London Hospitals
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
10 year predicted cardiovascular risk
Time Frame: AT time of clinic attendence
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AT time of clinic attendence
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
coronary heart disease risk
Time Frame: at time of clinic attendence
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at time of clinic attendence
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Barry S Peters, MB BS. MD, King's College London
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2005
Primary Completion (Actual)
September 1, 2006
Study Completion (Actual)
November 1, 2006
Study Registration Dates
First Submitted
November 16, 2009
First Submitted That Met QC Criteria
November 16, 2009
First Posted (Estimate)
November 17, 2009
Study Record Updates
Last Update Posted (Estimate)
November 17, 2009
Last Update Submitted That Met QC Criteria
November 16, 2009
Last Verified
November 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 05/Q0702/156
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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