Clinical trial NCT01637233: MARCH Central Nervous System Substudy
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV-1 Infection
Keywords: HIV-1 infection
neurocognitive function
switch study
Lead sponsor: Kirby Institute
Sponsor class: OTHER_GOV
First posted: 2012-07-11
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: participants in the MARCH main study who are eligible for the CNS substudy and provide written informed consent for participation

Brief 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.

Detailed description: this is detailed above, this is a substudy of MARCH

Eligibility criteria: 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

Primary outcomes:
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
timeFrame: 96 weeks
measure: 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
timeFrame: 96 weeks
Secondary outcomes:
measure: 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
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Hospital Ramos Mejía
city: Buenos Aires
country: Argentina
facility: Fundación IDEAA
city: Rosario
country: Argentina
facility: CAICI
city: Bangkok
country: Thailand
facility: Chulalongkorn University Hospital
city: Brighton
country: United Kingdom
facility: Brighton & Sussex University NHS Trust
state: Sussex
city: London
country: United Kingdom
facility: Imperial Healthcare, St. Mary's Hospital
Study officials:
affiliation: Imperial Healthcare, London, UK
name: Alan Winston, MD
role: PRINCIPAL_INVESTIGATOR
References: