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

This study is currently recruiting participants.
Verified March 2013 by Holdsworth House Medical Practice
Sponsor:
Information provided by (Responsible Party):
Dr. Mark Bloch, Holdsworth House Medical Practice
ClinicalTrials.gov Identifier:
NCT01436136
First received: September 14, 2011
Last updated: March 18, 2013
Last verified: March 2013

September 14, 2011
March 18, 2013
October 2011
March 2014   (final data collection date for primary outcome measure)
The primary outcome measure is percentage of patients with a reduction of Framingham risk score of at least 10% at week 52. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
The primary outcome measure is percentage of patients with a reduction of Framingham risk score of at least 10% at week 52.
Same as current
Complete list of historical versions of study NCT01436136 on ClinicalTrials.gov Archive Site
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Reducing Cardiovascular Disease (CVD) Risk in HIV on Antiretroviral Therapy Over 12 Months
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

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

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Interventional
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Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • HIV-1 Infection
  • Cardiovascular Disease
  • 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.
  • 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.
  • Active Comparator: 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: Other: Control
  • Active Comparator: 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.
    Intervention: Other: Intervention Group
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
March 2014
March 2014   (final data collection date for primary outcome measure)

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
Both
50 Years and older
No
Contact: Mark T Bloch, MBBS +61 02 9331 7228 mark.bloch@holdsworthhouse.com.au
Contact: Avindra E Jayewardene +61 02 9331 7228 avindra.jayewardene@holdsworthhouse.com.au
Australia
 
NCT01436136
Reducing CVD risk in HIV
No
Dr. Mark Bloch, Holdsworth House Medical Practice
Holdsworth House Medical Practice
Not Provided
Principal Investigator: Mark T Bloch Australian Health Practitioner Regulation Agency
Holdsworth House Medical Practice
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP