Cardiovascular Risk Evaluation and Antiretrovirals in HIV (CREATE1)
This study has been completed.
Sponsor:
King's College London
Collaborator:
Guy's and St Thomas' NHS Foundation Trust
Information provided by:
King's College London
ClinicalTrials.gov Identifier:
NCT01015092
First received: November 16, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | November 16, 2009 | ||||
| Last Updated Date | November 16, 2009 | ||||
| Start Date ICMJE | June 2005 | ||||
| Primary Completion Date | September 2006 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
10 year predicted cardiovascular risk [ Time Frame: AT time of clinic attendence ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
coronary heart disease risk [ Time Frame: at time of clinic attendence ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Cardiovascular Risk Evaluation and Antiretrovirals in HIV | ||||
| Official Title ICMJE | Predicted 10-year Coronary Heart Disease Risk in HIV and Implications for Clinical Management: the CREATE Study | ||||
| Brief 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 |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | All HIV outpatients patients attending two London Hospitals |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | unselected HIV outpatient attendees
All HIV patients attending for general HIV care at 2 London Hospitals |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 1024 | ||||
| Completion Date | November 2006 | ||||
| Primary Completion Date | September 2006 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United Kingdom | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01015092 | ||||
| Other Study ID Numbers ICMJE | 05/Q0702/156 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Dr Barry Stephen Peters, Kings College London | ||||
| Study Sponsor ICMJE | King's College London | ||||
| Collaborators ICMJE | Guy's and St Thomas' NHS Foundation Trust | ||||
| Investigators ICMJE |
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| Information Provided By | King's College London | ||||
| Verification Date | November 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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