Trial record 13 of 40 for:    " August 17, 2011":" September 16, 2011"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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


Condition Intervention
HIV-1 Infection
Cardiovascular Disease
Other: Control
Other: Intervention Group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Holdsworth House Medical Practice:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 80
Study Start Date: October 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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: 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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01436136

Contacts
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

Locations
Australia, New South Wales
Holdsworth House Medical Practice Recruiting
Sydney, New South Wales, Australia, 2010
Contact: Mark T Bloch, MBBS    +61 02 9331 7228    Mark.Bloch@holdsworthhouse.com.au   
Contact: Trina M Vincent, RN    +61 02 9331 7228    Trina.Vincent@holdsworthhouse.com.au   
Principal Investigator: Mark T Bloch, MBBS         
Sponsors and Collaborators
Holdsworth House Medical Practice
Investigators
Principal Investigator: Mark T Bloch Australian Health Practitioner Regulation Agency
  More Information

No publications provided

Responsible Party: Dr. Mark Bloch, Doctor, Holdsworth House Medical Practice
ClinicalTrials.gov Identifier: NCT01436136     History of Changes
Other Study ID Numbers: Reducing CVD risk in HIV
Study First Received: September 14, 2011
Last Updated: March 18, 2013
Health Authority: Australia: National Health and Medical Research Council

Keywords provided by Holdsworth House Medical Practice:
Cardiovascular disease
HIV
Antiretroviral treatment
team interventions
Framingham risk score

Additional relevant MeSH terms:
Cardiovascular Diseases
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on August 01, 2014