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MARCH Central Nervous System Substudy

NCT01637233 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 28

Last updated 2016-01-20

No results posted yet for this study

Summary

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:

1. Neurocognitive function as assessed by a computerised testing battery called CogState;
2. changes in cerebral metabolites as measured via 1H Magnetic Resonance Spectroscopy (1H-MRS)

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.

Conditions

  • HIV-1 Infection

Interventions

DRUG

Arm 1 TNucleotide Analogue Reverse Transcriptase Inhibitors and Boosted Protease Inhibitors

NRTI+PI

DRUG

Arm 2 Maraviroc and Protease Inhibitors

maraviroc + PI

DRUG

Arm 3 Maraviroc and Nucleotide Analogue Reverse Transcriptase Inhibitors

maraviroc + NRTI

Sponsors & Collaborators

  • Kirby Institute

    lead OTHER_GOV

Principal Investigators

  • Alan Winston, MD · Imperial Healthcare, London, UK

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • Argentina
  • Thailand
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01637233 on ClinicalTrials.gov