Condition category
Infections and Infestations
Date applied
20/02/2015
Date assigned
02/03/2015
Last edited
10/03/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Maria Saumoy

ORCID ID

Contact details

Feixa Llarga s/n
Hospitalet de Llobregat
08907
Spain

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

Sponsor information

Organisation

Bellvitge University Hospital

Sponsor details

c/o Daniel Podzamczer
Feixa Llarga s/n
Hospitalet de Llobregat
08907
Spain

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes