MARCH Central Nervous System Substudy
- Conditions
- HIV-1 Infection
- Interventions
- Drug: Arm 1 TNucleotide Analogue Reverse Transcriptase Inhibitors and Boosted Protease InhibitorsDrug: Arm 3 Maraviroc and Nucleotide Analogue Reverse Transcriptase InhibitorsDrug: Arm 2 Maraviroc and Protease Inhibitors
- Registration Number
- NCT01637233
- Lead Sponsor
- Kirby Institute
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
- 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
- Pre-existing CNS diseases
- Recent head injury (past three months)
- Current history of major depression or psychosis
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description NRTI + PI Arm 1 TNucleotide Analogue Reverse Transcriptase Inhibitors and Boosted Protease Inhibitors This is the randomisation of the main study, Arm 1 maraviroc + NRTI Arm 3 Maraviroc and Nucleotide Analogue Reverse Transcriptase Inhibitors this is the randomisation of the main study, Arm 3 maraviroc + PI Arm 2 Maraviroc and Protease Inhibitors this is the randomisation of the main study, Arm 2
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method 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 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
Trial Locations
- Locations (6)
Hospital Ramos Mejía
🇦🇷Buenos Aires, Argentina
Fundación IDEAA
🇦🇷Buenos Aires, Argentina
CAICI
🇦🇷Rosario, Argentina
Chulalongkorn University Hospital
🇹🇭Bangkok, Thailand
Brighton & Sussex University NHS Trust
🇬🇧Brighton, Sussex, United Kingdom
Imperial Healthcare, St. Mary's Hospital
🇬🇧London, United Kingdom