Extrait

Background and study aims HIV is a virus that attacks the immune system, weakening the body's ability to fight infections and disease. HIV is treated with a combination of antiretroviral drugs which stops the virus replicating in the body and allows your immune system to recover. This prevents you from developing many illnesses related to the HIV virus. However, some people can still develop attention and memory problems known as cognitive function impairment. The aim of this study is to see if adding in a new antiretroviral drug has an effect on cognitive function. Who can participate? Patients aged 18 or over with HIV and clinically significant cognitive impairment. What does the study involve? The study is up to 16 weeks long and there are a total of 6 visits. For 8 weeks participants receive the new medication in addition to their current treatment. At the start and end of the study participants have a lumbar puncture (where a needle is inserted into the lower part of the spine) and an MRI scan and on three occasions complete a series of tests to assess their brain function. There are safety blood tests at all visits. What are the possible benefits and risks of participating? There is no direct benefit to the participants but the information gained from this study may be of benefit in the treatment of HIV-infected patients in the future. There are possible side effects of the treatment that include diarrhoea, vomiting, rash, headache and tiredness. There are also risks associated with having a lumbar puncture, including pain at the site and headaches. Where is the study run from? Imperial College Healthcare NHS Trust (UK) When is the study starting and how long is it expected to run for? October 2015 to September 2016 Who is funding the study? National Institute for Health Research (UK) Who is the main contact? Mr Kenneth Legg [email protected]

Critère d'inclusion

• HIV

Liens

• isrctn
• ictrp