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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01436136




Registration number
NCT01436136
Ethics application status
Date submitted
14/09/2011
Date registered
19/09/2011
Date last updated
12/05/2015

Titles & IDs
Public title
Reducing Cardiovascular Disease (CVD) Risk in HIV on Antiretroviral Therapy Over 12 Months
Scientific 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
Secondary ID [1] 0 0
Reducing CVD risk in HIV
Universal Trial Number (UTN)
Trial acronym
CVD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV-1 Infection 0 0
Cardiovascular Disease 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Control
Other interventions - Intervention Group

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.

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.


Other interventions: 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 interventions: 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 code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The primary outcome measure is percentage of patients with a reduction of Framingham risk score of at least 10% at week 52.
Timepoint [1] 0 0
12 months

Eligibility
Key inclusion 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
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2014
Sample size
Target
Accrual to date
Final
92
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Holdsworth House Medical Practice - Sydney
Recruitment postcode(s) [1] 0 0
2010 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
Holdsworth House Medical Practice
Address
Country

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/ct2/show/NCT01436136
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Mark T Bloch
Address 0 0
Australian Health Practitioner Regulation Agency
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01436136