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

Holdsworth House Medical Practice

Status: Completed

Conditions: HIV-1 Infection; Cardiovascular Disease

Treatments: Other: Control; Other: Intervention Group

Study type: Interventional

Funder types: Other

Identifiers

NCT01436136

Reducing CVD risk in HIV

Details and patient eligibility

About

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

Enrollment: 92 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

intervention study intervention arm

Inclusion criteria:

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

Exclusion criteria for intervention study

1. Life expectancy < 1yr
2. Unable to undertake exercise
3. Drug dependency
4. Cognitive impairment affecting ability to participate in study
5. 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)
6. 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)

1. Documented HIV-1 infection
2. Age 50 years or older
3. Stable on ART ≥3/12
4. Undetectable plasma HIV RNA (<50 copies/ml)
5. Moderate or high Framingham risk score (>10%)
6. Life expectancy > 12 months
7. Regular patient under care of non-director physician

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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92 participants in 2 patient groups

Intervention group

Active Comparator group

Description:

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.

Treatment:

Other: Control

Usual care (control) group

Active Comparator group

Description:

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.

Treatment:

Other: Intervention Group