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Cardiovascular Risk Evaluation and Antiretrovirals in HIV (CREATE1)

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ClinicalTrials.gov Identifier: NCT01015092
Recruitment Status : Completed
First Posted : November 17, 2009
Last Update Posted : November 17, 2009
Sponsor:
Collaborator:
Guy's and St Thomas' NHS Foundation Trust
Information provided by:
King's College London

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Condition or disease
Cardiovascular Risk HIV Infections

Study Design
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Study Type : Observational
Actual Enrollment : 1024 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Predicted 10-year Coronary Heart Disease Risk in HIV and Implications for Clinical Management: the CREATE Study
Study Start Date : June 2005
Actual Primary Completion Date : September 2006
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
unselected HIV outpatient attendees
All HIV patients attending for general HIV care at 2 London Hospitals


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 10 year predicted cardiovascular risk [ Time Frame: AT time of clinic attendence ]

Secondary Outcome Measures :
  1. coronary heart disease risk [ Time Frame: at time of clinic attendence ]

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All HIV outpatients patients attending two London Hospitals
Criteria

Inclusion Criteria:

  • Serologically proven HIV infection
  • Attending general HIV outpatient clinic

Exclusion Criteria:

  • Attending a specialist outpatient clinic which might lead to recruitment bias
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01015092


Locations
United Kingdom
Guys & ST Thomas' Foundation Hospitals
London, United Kingdom, SE30AA
Sponsors and Collaborators
King's College London
Guy's and St Thomas' NHS Foundation Trust
Investigators
Principal Investigator: Barry S Peters, MB BS. MD King's College London
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Dr Barry Stephen Peters, Kings College London
ClinicalTrials.gov Identifier: NCT01015092     History of Changes
Other Study ID Numbers: 05/Q0702/156
First Posted: November 17, 2009    Key Record Dates
Last Update Posted: November 17, 2009
Last Verified: November 2009

Keywords provided by King's College London:
HIV
Cardiovascular
Coronary hear disease
HAART
antiretroviral

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases