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

NCT ID: NCT01436136

Last Updated: 2015-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2014-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention group

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.

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: 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.

Usual care (control) group

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.

Group Type: ACTIVE_COMPARATOR

Intervention Group

Intervention Type: 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.

Interventions

Control

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 Type: OTHER

Intervention Group

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.

Intervention Type: OTHER

Eligibility Criteria

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

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

Exclusion Criteria

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Holdsworth House Medical Practice

OTHER

Sponsor Role: lead

Responsible Party

Dr. Mark Bloch

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mark T Bloch

Role: PRINCIPAL_INVESTIGATOR

Australian Health Practitioner Regulation Agency

Locations

Holdsworth House Medical Practice

Sydney, New South Wales, Australia

Countries

Australia

Other Identifiers

Reducing CVD risk in HIV

Identifier Type: -

Identifier Source: org_study_id