CSF inflammatory markers after adding maraviroc to DRV/r monotherapy

• Research type

  Research Study

• Full title

  A phase IV, open-label, single centre, single-arm, pilot study to assess Cerebrospinal fluid INflammatory markers after Addition of Maraviroc to MONotherapy darunavir/ritonavir – The CINAMMON Study SSAT046

• IRAS ID

  102430

• Contact name

  Brian Gazzard

• Sponsor organisation

  St Stephen's AIDS Trust

• Eudract number

  2012-000649-11

• ISRCTN Number

  N/A

• Research summary

  The purpose of the study is to investigate the possible benefits of giving the anti-HIV drug maraviroc to people who are taking darunavir/ritonavir alone for their HIV treatment. Many People'successfully take only darunavir/ritonavir treatment for their HIV. However, there are some concerns that this treatment may not reach some areas of the body, such as the brain and spinal cord (central nervous system or CNS), as effectively as it does the bloodstream. There is already a large clinical study looking at any differences between ??conventional?? HIV treatment with 3 drugs and single drug treatment with a protease inhibitor, also called PI monotherapy, such as darunavir/ritonavir. This includes differences in the effects on the CNS. However, this study will only be finished in 2013. We know that maraviroc can reach the CNS very effectively. We will investigate the effect of adding maraviroc to darunavir/ritonavir monotherapy by looking at levels of inflammation within thflud that surrounds the CNS, called cerebrospinaflud or CSF. Maraviroc is a licensed drug for HIV treatment in people who have failed other HIV treatments. It showed good results in 2 clinical studies when it was taken by people who had already received and developed resistance to previous HIV treatments. This study will also investigate safety (in terms of other side effects and the routine blood tests which are ordinarily used to monitor treatment) as well as monitor effectiveness (viral load and CD4 counts) when maraviroc is taken from week 12 to 36 on top of normal treatment of darunavir/ritonavir monotherapy. It will also investigate brain (neurocognitive) functioning and activities of daily living with a computer test and some written tests. Up to 30 patients HIV-1 infected adults who are currently receiving darunavir/ritonavir monotherapy will participate in this trial. This study is an open-label and single arm study.

• REC name

  London - South East Research Ethics Committee

• REC reference

  12/LO/0545

• Date of REC Opinion

  22 Aug 2012

• REC opinion

  Further Information Favourable Opinion