MARCH Central Nervous System Substudy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Kirby Institute
ClinicalTrials.gov Identifier:
NCT01637233
First received: June 27, 2012
Last updated: July 17, 2014
Last verified: July 2014

June 27, 2012
July 17, 2014
June 2012
January 2015   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
    using CogState testing at 5 timepoints, weeks 0, 12, 24, 48, 96
  • 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 ] [ Designated as safety issue: No ]

    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
Same as current
Complete list of historical versions of study NCT01637233 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]

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
Same as current
Not Provided
Not Provided
 
MARCH Central Nervous System Substudy
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).

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.

this is detailed above, this is a substudy of MARCH

Observational
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

plasma and CSF

Probability Sample

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

HIV-1 Infection
  • Drug: Arm 1 TNucleotide Analogue Reverse Transcriptase Inhibitors and Boosted Protease Inhibitors
    NRTI+PI
    Other Names:
    • tenofovir
    • emtricitabine
    • zidovudine
    • lamivudine
    • abacavir
    • Ritonavir
    • lopinavir
    • darunavir
    • atazanavir
    • fosamprenavir
  • Drug: Arm 2 Maraviroc and Protease Inhibitors
    maraviroc + PI
    Other Names:
    • maraviroc
    • Ritonavir
    • lopinavir
    • darunavir
    • atazanavir
    • fosamprenavir
  • Drug: Arm 3 Maraviroc and Nucleotide Analogue Reverse Transcriptase Inhibitors
    maraviroc + NRTI
    Other Names:
    • maraviroc
    • tenofovir
    • emtricitabine
    • zidovudine
    • lamivudine
    • abacavir
  • NRTI + PI
    This is the randomisation of the main study, Arm 1
    Intervention: Drug: Arm 1 TNucleotide Analogue Reverse Transcriptase Inhibitors and Boosted Protease Inhibitors
  • maraviroc + PI
    this is the randomisation of the main study, Arm 2
    Intervention: Drug: Arm 2 Maraviroc and Protease Inhibitors
  • maraviroc + NRTI
    this is the randomisation of the main study, Arm 3
    Intervention: Drug: Arm 3 Maraviroc and Nucleotide Analogue Reverse Transcriptase Inhibitors
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
28
January 2016
January 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom,   Argentina,   Thailand
 
NCT01637233
MARCH-Kirby CNS, 2011-002107-15
Yes
Kirby Institute
Kirby Institute
Not Provided
Principal Investigator: Alan Winston, MD Imperial Healthcare, London, UK
Kirby Institute
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP