MARCH Central Nervous System Substudy

Kirby Institute

Status: Completed

Conditions: HIV-1 Infection

Treatments: Drug: Arm 2 Maraviroc and Protease Inhibitors; Drug: Arm 1 TNucleotide Analogue Reverse Transcriptase Inhibitors and Boosted Protease Inhibitors; Drug: Arm 3 Maraviroc and Nucleotide Analogue Reverse Transcriptase Inhibitors

Study type: Observational

Funder types: Other

Identifiers

NCT01637233

MARCH-Kirby CNS

2011-002107-15 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

this is detailed above, this is a substudy of MARCH

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

28 participants in 3 patient groups

NRTI + PI

Description:

This is the randomisation of the main study, Arm 1

Treatment:

Drug: Arm 1 TNucleotide Analogue Reverse Transcriptase Inhibitors and Boosted Protease Inhibitors

maraviroc + PI

Description:

this is the randomisation of the main study, Arm 2

Treatment:

Drug: Arm 2 Maraviroc and Protease Inhibitors

maraviroc + NRTI

Description:

this is the randomisation of the main study, Arm 3

Treatment:

Drug: Arm 3 Maraviroc and Nucleotide Analogue Reverse Transcriptase Inhibitors