MARCH Central Nervous System Substudy
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ClinicalTrials.gov Identifier: NCT01637233 |
Recruitment Status
:
Completed
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;
- 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.
Condition or disease | Intervention/treatment |
---|---|
HIV-1 Infection | Drug: Arm 1 TNucleotide Analogue Reverse Transcriptase Inhibitors and Boosted Protease Inhibitors Drug: Arm 2 Maraviroc and Protease Inhibitors Drug: Arm 3 Maraviroc and Nucleotide Analogue Reverse Transcriptase Inhibitors |
Study Type : | Observational |
Actual Enrollment : | 28 participants |
Time Perspective: | Prospective |
Official 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). |
Study Start Date : | June 2012 |
Actual Primary Completion Date : | December 2015 |
Actual Study Completion Date : | December 2015 |

Group/Cohort | Intervention/treatment |
---|---|
NRTI + PI
This is the randomisation of the main study, Arm 1
|
Drug: Arm 1 TNucleotide Analogue Reverse Transcriptase Inhibitors and Boosted Protease Inhibitors
NRTI+PI
Other Names:
|
maraviroc + PI
this is the randomisation of the main study, Arm 2
|
Drug: Arm 2 Maraviroc and Protease Inhibitors
maraviroc + PI
Other Names:
|
maraviroc + NRTI
this is the randomisation of the main study, Arm 3
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Drug: Arm 3 Maraviroc and Nucleotide Analogue Reverse Transcriptase Inhibitors
maraviroc + NRTI
Other Names:
|
- 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
- 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
- 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
Biospecimen Retention: Samples Without DNA

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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 |
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

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
Argentina | |
Hospital Ramos Mejía | |
Buenos Aires, Argentina, C1221ADC | |
Fundación IDEAA | |
Buenos Aires, Argentina, C1405CKC | |
CAICI | |
Rosario, Argentina | |
Thailand | |
Chulalongkorn University Hospital | |
Bangkok, Thailand, 10330 | |
United Kingdom | |
Brighton & Sussex University NHS Trust | |
Brighton, Sussex, United Kingdom, BN21ES, | |
Imperial Healthcare, St. Mary's Hospital | |
London, United Kingdom, W2 |
Principal Investigator: | Alan Winston, MD | Imperial Healthcare, London, UK |
Responsible Party: | Kirby Institute |
ClinicalTrials.gov Identifier: | NCT01637233 History of Changes |
Other Study ID Numbers: |
MARCH-Kirby CNS 2011-002107-15 ( EudraCT Number ) |
First Posted: | July 11, 2012 Key Record Dates |
Last Update Posted: | January 20, 2016 |
Last Verified: | January 2016 |
Keywords provided by Kirby Institute:
HIV-1 infection neurocognitive function switch study |
Additional relevant MeSH terms:
Ritonavir Lopinavir Darunavir Atazanavir Sulfate HIV Protease Inhibitors Fosamprenavir Tenofovir Lamivudine Emtricitabine Zidovudine Maraviroc Abacavir Protease Inhibitors |
Reverse Transcriptase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Nucleic Acid Synthesis Inhibitors Antimetabolites CCR5 Receptor Antagonists |