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

Cardiovascular Disease Clinical Trial

— CVD  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01436136
• Other study ID #: Reducing CVD risk in HIV
• Status: Completed
• Phase: N/A
• First received: September 14, 2011
• Last updated: May 10, 2015
• Start date: October 2011
• Est. completion date: June 2014

Study information

• Verified date: May 2015
• Source: Holdsworth House Medical Practice
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: National Health and Medical Research Council
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• HIV-1 Infection

Intervention

Other:
• 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 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.

Locations

Country	Name	City	State
Australia	Holdsworth House Medical Practice	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Holdsworth House Medical Practice

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No