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CSF inflammatory markers and neurocognitive function after addition of maraviroc to monotherapy darunavir/ritonavir in stable HIV patients: the CINAMMON study

A Correction to this article was published on 09 January 2018

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Abstract

CINAMMON is a phase IV, open-label, single-arm, pilot study assessing maraviroc (MVC) in the central nervous system (CNS) when added to darunavir/ritonavir monotherapy (DRV/r) in virologically suppressed HIV-infected subjects. CCR5 tropic participants on DRV/r were recruited. Participants remained on DRV/r for 12 week (w) (control phase). MVC 150 mg qd was added w12–w36 (intervention phase). Lumbar puncture (LP) and neurocognitive function (Cogstate) examinations scheduled at baseline, w12 and w36; MRI before w12, again at w36. Primary endpoint was CSF inflammatory marker changes during intervention phase. Secondary endpoints included changes in NC function and MRI parameters. CSF/plasma DRV/r concentrations measured at w12 and w36, MVC at w36. Nineteen patients recruited, 15 completed (17M, 2F). Dropouts: headache (2), knee problem (could not attend, 1), personal reasons (1). Mean age (range) 45.4 years (27.2–65.1), 13/19 white, 10/19 MSM. No changes in selected CSF markers were seen w12–w36. Overall NC function did not improve w12–w36: total age adjusted z score improved by 0.27 (weighted paired t test; p = 0.11); for executive function only, age adjusted z score improved by 0.54 (p = 0.03). MRI brain parameters unchanged. DRV plasma:CSF concentration ratio unchanged between w12 (132) and w36 (112; p = 0.577, Wilcoxon signed-rank). MVC plasma:CSF concentration ratio was 35 at w36. No changes in neuroinflammatory markers seen. In this small study, addition of 24w MVC 150 mg qd to stable DRV/r monotherapy showed possible improvement in executive function with no global NC effect. Learning effect cannot be excluded. This effect should be further evaluated.

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  • 09 January 2018

    Due to a production error the bottom portion of Figure 1 was omitted. The corrected figure is given below.

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Acknowledgements

Many thanks to all of the participants and staff in this study in both London and Barcelona. CINAMMON (SSAT046) was funded by ViiV Healthcare and supported by Pfizer. The study sponsor was the St Stephen’s AIDS Trust (www.ssat.org.uk).

Thanks also to the following people for their help and support, including analyses of the neuroinflammatory markers and imaging: David Back, Miles Chapman, Roger Chinn, Dietmar Fuchs, Chris Higgs, Paul Holmes, Lesley Honeyfield, Zeenat Karolia, Gary Lo, Michael Lunn, Michael Rayment, Alex Rovira and Adam Waldmann.

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Correspondence to T. J. Barber.

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A correction to this article is available online at https://doi.org/10.1007/s13365-017-0613-1.

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Barber, T.J., Imaz, A., Boffito, M. et al. CSF inflammatory markers and neurocognitive function after addition of maraviroc to monotherapy darunavir/ritonavir in stable HIV patients: the CINAMMON study. J. Neurovirol. 24, 98–105 (2018). https://doi.org/10.1007/s13365-017-0600-6

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  • DOI: https://doi.org/10.1007/s13365-017-0600-6

Keywords

  • HIV
  • Neurocognitive
  • Inflammatory
  • Maraviroc