MARCH Central Nervous System Substudy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

28 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2015-12-31

Brief Summary

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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:

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.

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Detailed Description

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this is detailed above, this is a substudy of MARCH

Conditions

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HIV-1 Infection

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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NRTI + PI

This is the randomisation of the main study, Arm 1

Arm 1 TNucleotide Analogue Reverse Transcriptase Inhibitors and Boosted Protease Inhibitors

Intervention Type DRUG

NRTI+PI

maraviroc + PI

this is the randomisation of the main study, Arm 2

Arm 2 Maraviroc and Protease Inhibitors

Intervention Type DRUG

maraviroc + PI

maraviroc + NRTI

this is the randomisation of the main study, Arm 3

Arm 3 Maraviroc and Nucleotide Analogue Reverse Transcriptase Inhibitors

Intervention Type DRUG

maraviroc + NRTI

Interventions

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Arm 1 TNucleotide Analogue Reverse Transcriptase Inhibitors and Boosted Protease Inhibitors

NRTI+PI

Intervention Type DRUG

Arm 2 Maraviroc and Protease Inhibitors

maraviroc + PI

Intervention Type DRUG

Arm 3 Maraviroc and Nucleotide Analogue Reverse Transcriptase Inhibitors

maraviroc + NRTI

Intervention Type DRUG

Other Intervention Names

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tenofovir emtricitabine zidovudine lamivudine abacavir Ritonavir lopinavir darunavir atazanavir fosamprenavir maraviroc Ritonavir lopinavir darunavir atazanavir fosamprenavir maraviroc tenofovir emtricitabine zidovudine lamivudine abacavir

Eligibility Criteria

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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