MARCH Central Nervous System Substudy

This study has been completed.

Sponsor:

Kirby Institute

ClinicalTrials.gov Identifier:

NCT01637233

First Posted: July 11, 2012

Last Update Posted: January 20, 2016

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This substudy is a prospective, observational, open-label, randomised study within the MARCH study. The purpose of this substudy is to investigate the changes in cerebral function parameters at 5 timepoints over 96 weeks of the three different treatment arms within the MARCH study. The investigators hypothesise that there will be improvements in cerebral function in those patients randomised, as part of the parent study, into the maraviroc arms.

the assessments in this CNS substudy will include:

Neurocognitive function as assessed by a computerised testing battery called CogState;

In those randomised to the maraviroc arms (arms 2 and 3) there is an optional Lumbar puncture at week 48. The cerebrospinal fluid will be used to measure maraviroc levels and an ultrasensitive CSF HIV-1 viral load. These results will be matched with levels in the plasma.

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Sampling Method:

Probability Sample

Study Population

participants in the MARCH main study who are eligible for the CNS substudy and provide written informed consent for participation

Criteria

Inclusion Criteria:

Provision of written, informed consent for participation in the substudy

Enrolled into the substudy either at or before the week 0 visit of the main study

Exclusion Criteria:

Pre-existing CNS diseases

Recent head injury (past three months)

Current history of major depression or psychosis

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01637233