A Study to Assess Cerebrospinal Fluid INflammatory Markers After Addition of Maraviroc to MONotherapy Darunavir/Ritonavir - The CINAMMON Study
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.
The investigators know that maraviroc can reach the CNS very effectively. The investigators in this study will investigate the effect of adding maraviroc to darunavir/ritonavir monotherapy by looking at levels of inflammation within the fluid that surrounds the CNS, called cerebrospinal fluid or CSF.
Maraviroc is a licensed drug for the treatment of HIV treatment.. It showed good results in 2 clinical studies when it was taken by people whose HIV virus had developed resistance to previous HIV treatments.
This study will also investigate safety as well as monitor effectiveness when patients take maraviroc is taken on top of normal treatment of darunavir/ritonavir monotherapy.
Maraviroc has been shown to be present in the fluid that surrounds the brain in people taking Maraviroc. It is not known if whether the presence of Maraviroc has any impact on brain function. Therefore this study will also investigate brain (neurocognitive) functioning with a computer test and some written tests.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
- Changes in inflammatory markers in CSF week 12 to week 36 [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]To investigate changes from week 12 to week 36 in inflammatory markers in CSF when maraviroc (150mg qd) is added to stable darunavir/ritonavir (800/100mg qd) monotherapy for 24 weeks
- CSF inflammatory markers from baseline to week 12 on darunavir/ritonavir monotherapy (control phase) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]To investigate changes in CSF inflammatory markers from baseline to week 12 on darunavir/ritonavir monotherapy (control phase)
|Study Start Date:||November 2012|
|Estimated Primary Completion Date:||November 2015 (Final data collection date for primary outcome measure)|
Experimental: Maraviroc, darunavir, ritonavir
Single-arm,assessing cerebrospinal fluid inflammatory markers after addition of maraviroc to patients stable on monotherapy darunavir/ritonavir
Please refer to this study by its ClinicalTrials.gov identifier: NCT01680536
|St Stephen's AIDS Trust|
|London, United Kingdom, SW10 9TH|