HIV-1 InfectionCVDNCT01436136
Reducing Cardiovascular Disease (CVD) Risk in HIV on Antiretroviral Therapy Over 12 Months
A study testing Intervention Group in people with HIV-1 Infection and Cardiovascular Disease, run by Holdsworth House Medical Practice at 1 site in Australia.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- HIV-1 Infection, Cardiovascular Disease
- What is being tested?
- Intervention Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteAustralia
- Study dates
- Oct 2011to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site
Holdsworth House Medical Practice
Sydney, New South Wales, 2010
About this study
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
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
- Being tested
- Control, Intervention Group
- Keywords
- Cardiovascular disease, HIV, Antiretroviral treatment, team interventions, Framingham risk score
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
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 GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | 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. Receives: Other: Control |
| Usual care (control) group | Active comparator | 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. Receives: Other: Intervention Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2011 (estimated)
- Study startOct 2011
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Holdsworth House Medical Practice
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Mark Bloch, Holdsworth House Medical Practice
- Investigators
- Mark T Bloch, Principal investigator, Australian Health Practitioner Regulation Agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01436136
- Sponsor's protocol ID
- Reducing CVD risk in HIV
- Acronym
- CVD
- Status last verified
- May 2015
- First submitted
- 14 Sep 2011
- Last updated
- 12 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01436136
- Acronym / sponsor ID
- CVD / Reducing CVD risk in HIV
- Conditions
- HIV-1 Infection, Cardiovascular Disease
- Keywords
- Cardiovascular disease, HIV, Antiretroviral treatment, team interventions, Framingham risk score
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Holdsworth House Medical PracticeUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 19 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Other: ControlPatients 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. |
| Usual care (control) group | Active comparator | Other: Intervention GroupWithin 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ControlGPs 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 |
| Intervention GroupPatients 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. | Other | Usual care (control) group |
Primary outcome
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
The primary outcome measure is percentage of patients with a reduction of Framingham risk score of at least 10% at week 52.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark T Bloch principal investigator
Australian Health Practitioner Regulation Agency
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group in people with HIV-1 Infection and Cardiovascular Disease, run by Holdsworth House Medical Practice at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2015.