Extrait

Background and study aims Successful treatment for HIV has lead to an ageing HIV-positive population with heart disease as the most common cause of death. The underlying cause of the increased risk of heart disease observed in HIV is not understood, and cannot be explained by traditional risk factors. Lifestyle intervention is recommended, with a low-fat diet to promote cholesterol reduction. The addition of functional foods (such as plant stanols and nuts) produces more dramatic reductions in cholesterol. This is based on evidence from the general population. This study will find out if the Ultimate Cholesterol Lowering Plan (UCLP) will have a similar effect in people who have raised cholesterol due to their HIV infection and treatment. Who can participate? Adults with HIV infection on stable antiretroviral therapy and raised cholesterol can take part in this study. What does the study involve? Participants will be randomly allocated to receive dietary advice on either reducing saturated fat alone, or together with increasing intake of nuts, plant stanols, soya protein, olive oil, beans and oats (components of the UCLP), delivered for 6 months. Results from blood tests, questionnaires and interviews will assess the impact of the UCLP on the risk of heart disease in adults with HIV infection on antiretroviral therapy. What are the possible benefits and risks of participating? If this diet can significantly reduce blood cholesterol levels, patients may reduce their risk of a heart attack. Risks to participants are not expected in this study. Potential malabsorption of fat soluble vitamins will be monitored. Participants will be directed to their doctor in the case of any health concerns arising during the study. Where is the study run from? The study is run from the Heart of England NHS Foundation Trust (UK), University Hospital Birmingham (UK) and Coventry and Warwickshire Partnership NHS Trust (UK). When is the study starting and how long is it expected to run for? The study starts in September 2013 and is expected to run until September 2016. Who is funding the study? National Institute for Health research (NIHR), UK. Who is the main contact? Mrs Clare Stradling [email protected]

Critère d'inclusion

• Topic: Infection; Subtopic: Infection (all Subtopics); Disease: Infectious diseases and microbiology

Liens

• ictrp
• isrctn