NCT01015092

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,024

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

November 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 17, 2009

Completed
Last Updated

November 17, 2009

Status Verified

November 1, 2009

Enrollment Period

1.3 years

First QC Date

November 16, 2009

Last Update Submit

November 16, 2009

Conditions

Cardiovascular RiskHIV Infections

Keywords

HIVCardiovascularCoronary hear diseaseHAARTantiretroviral

Outcome Measures

Primary Outcomes (1)

  • 10 year predicted cardiovascular risk

    AT time of clinic attendence

Secondary Outcomes (1)

  • coronary heart disease risk

    at time of clinic attendence

Study Arms (1)

unselected HIV outpatient attendees

All HIV patients attending for general HIV care at 2 London Hospitals

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All HIV outpatients patients attending two London Hospitals

You may qualify if:

  • Serologically proven HIV infection
  • Attending general HIV outpatient clinic

You may not qualify if:

  • Attending a specialist outpatient clinic which might lead to recruitment bias

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guys & ST Thomas' Foundation Hospitals

London, SE30AA, United Kingdom

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Barry S Peters, MB BS. MD

    King's College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 16, 2009

First Posted

November 17, 2009

Study Start

June 1, 2005

Primary Completion

September 1, 2006

Study Completion

November 1, 2006

Last Updated

November 17, 2009

Record last verified: 2009-11

Locations

GB(1)