The effect of an intensive intervention on life style in cardiovascular risk in an HIV-infected cohort with moderate to high cardiovascular risk

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN11313360

Enrollment

Registered

2015-03-02

Start date

2008-03-17

Completion date

Unknown

Last updated

2021-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV-infected patients, virologically controlled and a cardiovascular risk measured by Framingham score >10% Infections and Infestations

Interventions

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 exerc

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
1. Changes in the lipid parameters 2. Framingham score Both measured at 36 months	—

Secondary

Measure	Time frame
1. Carotid-intima media thickness 2. Cardiovascular biomarker changes Both measured at 36 months	—

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026