Reducing Cardiovascular Disease (CVD) Risk in HIV on Antiretroviral Therapy Over 12 Months

NCT01436136 | Completed

• 1 other identifier: Reducing CVD risk in HIV
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

This is a cohort study which follows two groups of participants over a 12 months period. One group will access a team approach to care with the aim of reducing their cardiovascular disease (CVD) risks from a team of doctors, nurses and health care professionals. The other group will continue to access standard care from their treating doctor. Both groups will have CVD risk score evaluated after a 12 month period. The team care approach will involve specific tests to measure CVD risk as well as smoking cessation, exercise and dietary advice and support, including monitoring such as blood pressure and cholesterol levels

Conditions

HIV-1 Infection; Cardiovascular Disease

Keywords

Cardiovascular disease; HIV; Antiretroviral treatment; team interventions; Framingham risk score

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure is percentage of patients with a reduction of Framingham risk score of at least 10% at week 52.

  The primary outcome measure is percentage of patients with a reduction of Framingham risk score of at least 10% at week 52.

  12 months

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

Patients randomised to the intervention group will follow an intensive 52 week period using a clinical protocol aimed to manage CVD risk in HIV individuals with the use of regular visits to a nurse led CVD risk management clinic, within a multi disciplinary approach to care with the involvement of treating physicians, nurses, dieticians, smoking cessation advisors and an exercise physiologist or personal trainer with the aim to reach their individualised CVD risk target.

Other: Control

Usual care (control) group

ACTIVE COMPARATOR

Within the context of an open, cohort study, GPs managing matched control patients allocated usual care will be unaware of the details of the intervention arm and asked to apply their usual pattern of patient visits and treatment strategies to achieve optimal reduction of CVD risk.

Other: Intervention Group

Interventions

Control OTHER

GPs managing matched control patients allocated usual care will be unaware of the details of the intervention arm and asked to apply their usual pattern of patient visits and treatment strategies to achieve optimal reduction of CVD risk.

Intervention group

Intervention Group OTHER

Patients randomised to the intervention group will follow an intensive 52 week period using a clinical protocol aimed to manage CVD risk in HIV individuals with the use of regular visits to a nurse led CVD risk management clinic, within a multi disciplinary approach to care with the involvement of treating physicians, nurses, dieticians, smoking cessation advisors and an exercise physiologist or personal trainer with the aim to reach their individualised CVD risk target.

Usual care (control) group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented HIV-1 infection
• Age 50 years or older
• Stable on ART ≥ 3/12
• Undetectable plasma HIV RNA (\< 50 copies/ml)
• Moderate or high Framingham CVD risk score
• Life expectancy \> 12 months
• Regular patient under care of non-director physician
• Willing to adhere to pharmacological CVD risk reduction intervention
• Willing to participate in lifestyle change advice intervention

You may not qualify if:

• Life expectancy \< 1yr
• Unable to undertake exercise
• Drug dependency
• Cognitive impairment affecting ability to participate in study
• Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (\> 5mI U/ml)
• Women of childbearing potential who are unwilling to use reliable contraception for the duration of the study
• Documented HIV-1 infection
• Age 50 years or older
• Stable on ART ≥3/12
• Undetectable plasma HIV RNA (\<50 copies/ml)
• Moderate or high Framingham risk score (\>10%)
• Life expectancy \> 12 months
• Regular patient under care of non-director physician

Sponsors & Collaborators

• Holdsworth House Medical Practice: lead

Study Sites (1)

Holdsworth House Medical Practice

Sydney, New South Wales, 2010, Australia

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Mark T Bloch

  Australian Health Practitioner Regulation Agency

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: September 14, 2011
• First Posted: September 19, 2011
• Study Start: October 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: May 12, 2015

Record last verified: 2015-05

Locations

AU (1)