Plain English Summary
Background and study aims
People living with HIV seem to be at a higher risk of cardiovascular disease than the general population. Possible reasons for this include the effect of the HIV virus, effects of antiretroviral drugs and classic cardiovascular risk factors, some of them being more prevalent in HIV-infected patients. Cardiovascular events (events that result in heart damage – for example heart attacks) have become a severe health problem as they are the first cause of death and disease in most countries in the developing world. As HIV infected patients are living longer, cardiovascular risks are an emerging problem in patients treated with HAART (a customised combination of medications to treat HIV). The aim of this study is to compare how well an intensive lifestyle intervention (program) performs against a standard intervention in reducing cardiovascular risk in HIV infected patients. The influence of HAART on the metabolism of HIV patients will also be investigated.
Who can participate?
HIV infected adults (aged at least 18) with a moderate to high cardiovascular risk.
What does the study involve?
Participants are randomly allocated into one of two different groups. Those in group 1 are assigned to the control group and are given routine care and advice on lifestyle. Those in group 2 are assigned to the intervention group and are given an intensive, multidisciplinary lifestyle intervention covering diet, exercise counseling and help to give up smoking. Statistical analyses are used to compare the cardiovascular risk of both groups of people 36 weeks after the start of the study.
What are the possible benefits and risks of participating?
There are no risk for the patients to participate in the study. The benefits are related with an improvement in the control and management of cardiovascular risk factors.
Where is the study run from?
Bellvitge University Hospital (Spain)
When is the study starting and how long is it expected to run for?
June 2007 to January 2012
Who is funding the study?
Bellvitge University Hospital (Spain)
Who is the main contact?
Dr Maria Saumoy
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
The effect of an intensive intervention on life style in cardiovascular risk in an HIV-infected cohort with moderate to high cardiovascular risk: a randomized trial
Acronym
Study hypothesis
1. An intensive lifestyle intervention may decrease cardiovascular risk in HIV infected patients with moderate to high cardiovascular risk (Framingham score > 10%).
2. Detection of subclinical carotid atherosclerosis by carotid ultrasound may improve cardiovascular risk stratification.
3. An intensive lifestyle intervention may prevent subclinical atherosclerosis progression.
Ethics approval
Bellvitge University Hospital, 10/05/2007, ref: PR096/07
Study design
Single center, pilot, randomized trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
HIV-infected patients, virologically controlled and a cardiovascular risk measured by Framingham score >10%
Intervention
Patients were randomized 1:1 into 2 groups:
1. The intervention group, in which patients underwent an intensive, multidisciplinary lifestyle intervention by a dietitian (diet and exercise counseling) and a preventive health physician (to stop smoking)
2. Control group, in which patients continued with routine care and received advice on lifestyle
Intervention type
Behavioural
Phase
Drug names
Primary outcome measures
1. Changes in the lipid parameters
2. Framingham score
Both measured at 36 months
Secondary outcome measures
1. Carotid-intima media thickness
2. Cardiovascular biomarker changes
Both measured at 36 months
Overall trial start date
15/06/2007
Overall trial end date
31/01/2012
Reason abandoned
Eligibility
Participant inclusion criteria
1. Documented HIV infection
2. Age older than 18 years
3. Stable antiretroviral regimen
4. Undetectable viral load for the previous 3 months
5. Cardiovascular risk estimation based on the FS greater than 10%
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
54 participants
Participant exclusion criteria
1. Previous cardiovascular disease
2. Diabetes mellitus
3. Microalbuminuria
4. Dyslipidemia due to hypothyroidism
5. Nephrotic syndrome or renal insufficiency (creatinine clearance< 50 mL/min)
6. Decompensated cirrhosis
Recruitment start date
17/03/2008
Recruitment end date
31/01/2012
Locations
Countries of recruitment
Spain
Trial participating centre
Bellvitge University Hospital
Feixa Llarga, s/n
L'Hospitalet de Llobregat
Barcelona
08907
Spain
Funders
Funder type
Not defined
Funder name
Bellvitge University Hospital (Spain)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
We are writing a paper with the results.
Intention to publish date
28/02/2015
Participant level data
Available on request
Results - basic reporting
Publication summary