Status:
COMPLETED
Reducing Cardiovascular Disease (CVD) Risk in HIV on Antiretroviral Therapy Over 12 Months
Lead Sponsor:
Holdsworth House Medical Practice
Conditions:
HIV-1 Infection
Cardiovascular Disease
Eligibility:
All Genders
50+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT01436136
Start Date
October 1 2011
End Date
June 1 2014
Last Update
May 12 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Holdsworth House Medical Practice
Sydney, New South Wales, Australia, 2010