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NCT Number: NCT01637233

MARCH Central Nervous System Substudy

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.

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Key information

Conditions

HIV-1 Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fundación IDEAA, Buenos Aires, Argentina

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About this study

this is detailed above, this is a substudy of MARCH

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arm 1 TNucleotide Analogue Reverse Transcriptase Inhibitors and Boosted Protease Inhibitors

Drug

NRTI+PI

Other names: tenofovir, emtricitabine, zidovudine, lamivudine, abacavir, Ritonavir, lopinavir, darunavir, atazanavir, fosamprenavir

Arm 2 Maraviroc and Protease Inhibitors

Drug

maraviroc + PI

Other names: maraviroc, Ritonavir, lopinavir, darunavir, atazanavir, fosamprenavir

Arm 3 Maraviroc and Nucleotide Analogue Reverse Transcriptase Inhibitors

Drug

maraviroc + NRTI

Other names: maraviroc, tenofovir, emtricitabine, zidovudine, lamivudine, abacavir

Primary outcomes

  1. To assess changes in NC function over 96 weeks, measured via a computerised testing battery in HIV-infected subjects stable on antiretroviral therapy randomised to three different treatment approaches

    Time frame: 96 weeks

    using CogState testing at 5 timepoints, weeks 0, 12, 24, 48, 96

  2. To assess changes in cerebral metabolites over 96 weeks, measured via 1H Magnetic Resonance Spectroscopy (1H-MRS), in HIV-infected subjects stable on antiretroviral therapy randomised to three different treatment approaches

    Time frame: 96 weeks

    Assessment of CNS metabolites via 1H-MRS at week 0, 48, 96

    • Cerebral metabolites in frontal white and grey voxels, and basal ganglia will be measured
    • Measurable metabolites will include assessment of neuronal markers, N-acetyl-aspartate, and inflammatory markers, myo-Inositols and Choline

Secondary outcomes

  1. to assess CSF HIV-1 RNA and CSF maraviroc concentration (in the MVC treatment arms) versus plasma HIV -1 RNA and MVC concentration after 48 weeks of therapy

    Time frame: 48 weeks

    A LP examination at week 48 (optional and only in the MVC treatment arms, and only if there is no contraindication to LP) to assess, with matched plasma samples:

    • CSF MVC concentration
    • CSF HIV-1 RNA
    • CSF biomarkers

Sponsors and collaborators

Lead sponsor

Kirby Institute

Other Gov

Registry information

Official study title

Maraviroc Switch Central Nervous System (CNS) Substudy: a Substudy of MARCH, a Randomised, Open-label Study to Evaluate the Efficacy and Safety of Maraviroc (MVC) as a Switch for Either Nucleoside or Nucleotide Analogue Reverse Transcriptase Inhibitors (N(t)RTI) or Boosted Protease Inhibitors (PI/r) in HIV-1 Infected Individuals With Stable, Well-controlled Plasma HIV-RNA While Taking Their First N(t)RTI + PI/r Regimen of Combination Antiretroviral Therapy (cART).

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jul 11, 2012
Registry last updated
Jan 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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