MARCH Central Nervous System Substudy

HIV-1 Infection Clinical Trial

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01637233
• Other study ID #: MARCH-Kirby CNS
• Secondary ID: 2011-002107-15
• Status: Completed
• Phase: N/A
• First received: June 27, 2012
• Last updated: January 18, 2016
• Start date: June 2012
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Kirby Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaAustralia: Department of Health and Ageing Therapeutic Goods AdministrationThailand: Ministry of Public HealthUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Observational

Clinical Trial 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.

Description:

this is detailed above, this is a substudy of MARCH

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• HIV-1 Infection

Intervention

Drug:
• Arm 1 TNucleotide Analogue Reverse Transcriptase Inhibitors and Boosted Protease Inhibitors
NRTI+PI
• Arm 2 Maraviroc and Protease Inhibitors
maraviroc + PI
• Arm 3 Maraviroc and Nucleotide Analogue Reverse Transcriptase Inhibitors
maraviroc + NRTI

Locations

Country	Name	City	State
Argentina	Fundación IDEAA	Buenos Aires
Argentina	Hospital Ramos Mejía	Buenos Aires
Argentina	CAICI	Rosario
Thailand	Chulalongkorn University Hospital	Bangkok
United Kingdom	Brighton & Sussex University NHS Trust	Brighton	Sussex
United Kingdom	Imperial Healthcare, St. Mary's Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Kirby Institute

Countries where clinical trial is conducted

Argentina,  Thailand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	using CogState testing at 5 timepoints, weeks 0, 12, 24, 48, 96	96 weeks	No
Primary	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	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	96 weeks	No
Secondary	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	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	48 weeks	Yes