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).

NCT01637233 COMPLETED

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.

Details

Lead sponsor	Kirby Institute
Status	COMPLETED
Enrolment	28
Start date	2012-06
Completion	2015-12

Conditions

• HIV-1 Infection

Interventions

• Arm 1 TNucleotide Analogue Reverse Transcriptase Inhibitors and Boosted Protease Inhibitors
• Arm 2 Maraviroc and Protease Inhibitors
• Arm 3 Maraviroc and Nucleotide Analogue Reverse Transcriptase Inhibitors

Primary outcomes

• 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 — 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 — 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

Countries

Argentina, Thailand, United Kingdom