The effect of an intensive intervention on life style in cardiovascular risk in an HIV-infected cohort with moderate to high cardiovascular risk
Not Applicable
Completed
- Conditions
- HIV-infected patients, virologically controlled and a cardiovascular risk measured by Framingham score >10%Infections and Infestations
- Registration Number
- ISRCTN11313360
- Lead Sponsor
- Bellvitge University Hospital
- Brief Summary
2016 results in https://pubmed.ncbi.nlm.nih.gov/26826629/ (added 10/05/2021)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 54
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%
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 1. Changes in the lipid parameters<br> 2. Framingham score<br><br> Both measured at 36 months<br>
- Secondary Outcome Measures
Name Time Method <br> 1. Carotid-intima media thickness<br> 2. Cardiovascular biomarker changes<br><br> Both measured at 36 months<br>