Clinical trial NCT01436136: Reducing Cardiovascular Disease (CVD) Risk in HIV on Antiretroviral Therapy Over 12 Months
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV-1 Infection
Cardiovascular Disease
Keywords: Cardiovascular disease
HIV
Antiretroviral treatment
team interventions
Framingham risk score
Lead sponsor: Holdsworth House Medical Practice
Sponsor class: OTHER
First posted: 2011-09-19
Enrollment: 92
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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


Eligibility 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

Primary outcomes:
measure: The primary outcome measure is percentage of patients with a reduction of Framingham risk score of at least 10% at week 52.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Holdsworth House Medical Practice
state: New South Wales
Study officials:
affiliation: Australian Health Practitioner Regulation Agency
name: Mark T Bloch
role: PRINCIPAL_INVESTIGATOR
References: