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

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

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Key information

Conditions

HIV-1 Infection Cardiovascular Disease Cardiovascular Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Holdsworth House Medical Practice

Sydney, New South Wales, 2010, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

intervention study intervention arm

Inclusion criteria

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

Exclusion criteria

for intervention study

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

Inclusion criteria

for intervention study control arm (Group 2)

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

Treatment and study plan

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

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.

Primary outcomes

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

Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

Holdsworth House Medical Practice

Other

Registry information

Official study title

Effectiveness of Team Intervention Over 12 Months in Reducing Modifiable CVD Risk Factors on Framingham 10yr Risk Scores Outcomes in HIV-1 Subjects on Antiretroviral Therapy

Acronym: CVD

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2014
First posted: Sep 19, 2011
Registry last updated: May 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed