Cardiovascular Risk Evaluation and Antiretrovirals in HIV | NCT01015092

Studies
Cardiovascular Risk Evaluation and Antiretrovirals in HIV

NCT01015092

Sponsor

King's College London

Status

Completed

Last Update Posted

Nov 17, 2009Estimated

Enrollment

1,024Actual

Phase

Not provided

Conditions

Cardiovascular Risk
HIV Infections

Interventions

Not provided

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2005

Primary Completion Date

Sep 2006Actual

Completion Date

Nov 2006Actual

First Submitted Date

Nov 16, 2009

First Submission Date that Met QC Criteria

Nov 16, 2009

First Posted Date

Nov 17, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 16, 2009

Last Update Posted Date

Nov 17, 2009Estimated

Name	Class
Guy's and St Thomas' NHS Foundation Trust	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,024Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
unselected HIV outpatient attendees		All HIV patients attending for general HIV care at 2 London Hospitals

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
10 year predicted cardiovascular risk		AT time of clinic attendence

Secondary Outcomes

Measure	Description	Time Frame
coronary heart disease risk		at time of clinic attendence

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All HIV outpatients patients attending two London Hospitals

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Barry S Peters, MB BS. MD	King's College London	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Guys & ST Thomas' Foundation Hospitals		London		SE30AA	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D015658	HIV Infections

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral

Browse Leaves

Not provided

Browse Branches

Not provided