Cardiovascular Risk Evaluation and Antiretrovirals in HIV (CREATE1)

This study has been completed.
Sponsor:
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
  Purpose

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
Cardiovascular Risk
HIV Infections

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by King's College London:

Primary Outcome Measures:
  • 10 year predicted cardiovascular risk [ Time Frame: AT time of clinic attendence ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • coronary heart disease risk [ Time Frame: at time of clinic attendence ] [ Designated as safety issue: No ]

Enrollment: 1024
Study Start Date: June 2005
Study Completion Date: November 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts
unselected HIV outpatient attendees
All HIV patients attending for general HIV care at 2 London Hospitals

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr Barry Stephen Peters, Kings College London
ClinicalTrials.gov Identifier: NCT01015092     History of Changes
Other Study ID Numbers: 05/Q0702/156
Study First Received: November 16, 2009
Last Updated: November 16, 2009
Health Authority: United Kingdom: National Health Service

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

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

ClinicalTrials.gov processed this record on October 23, 2014