---
title: MARCH Central Nervous System Substudy
nct_id: NCT01637233
overall_status: COMPLETED
sponsor: Kirby Institute
study_type: OBSERVATIONAL
primary_condition: HIV-1 Infection
countries: Argentina, Thailand, United Kingdom
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01637233.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01637233"
ct_last_update_post_date: 2016-01-20
last_seen_at: "2026-05-12T07:29:22.585Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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).

**NCT ID:** [NCT01637233](https://clinicaltrials.gov/study/NCT01637233)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 28
- **Lead Sponsor:** Kirby Institute
- **Conditions:** HIV-1 Infection
- **Start Date:** 2012-06
- **Completion Date:** 2015-12
- **CT.gov Last Update:** 2016-01-20

## 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

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **NRTI + PI** — This is the randomisation of the main study, Arm 1
- **maraviroc + PI** — this is the randomisation of the main study, Arm 2
- **maraviroc + NRTI** — this is the randomisation of the main study, Arm 3

## Interventions

- **Arm 1 TNucleotide Analogue Reverse Transcriptase Inhibitors and Boosted Protease Inhibitors** (DRUG) — NRTI+PI
- **Arm 2 Maraviroc and Protease Inhibitors** (DRUG) — maraviroc + PI
- **Arm 3 Maraviroc and Nucleotide Analogue Reverse Transcriptase Inhibitors** (DRUG) — maraviroc + NRTI

## 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** _(time frame: 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** _(time frame: 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 Outcomes

- **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** _(time frame: 48 weeks)_

## Locations (6)

- Fundación IDEAA, Buenos Aires, Buenos Aires, Argentina
- Hospital Ramos Mejía, Buenos Aires, Argentina
- CAICI, Rosario, Argentina
- Chulalongkorn University Hospital, Bangkok, Bangkok, Thailand
- Brighton & Sussex University NHS Trust, Brighton, Sussex, United Kingdom
- Imperial Healthcare, St. Mary's Hospital, London, United Kingdom

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.fundación ideaa|buenos aires|buenos aires|argentina` — added _(2026-05-12)_
- `locations.hospital ramos mejía|buenos aires||argentina` — added _(2026-05-12)_
- `locations.caici|rosario||argentina` — added _(2026-05-12)_
- `locations.chulalongkorn university hospital|bangkok|bangkok|thailand` — added _(2026-05-12)_
- `locations.brighton & sussex university nhs trust|brighton|sussex|united kingdom` — added _(2026-05-12)_
- `locations.imperial healthcare, st. mary's hospital|london||united kingdom` — added _(2026-05-12)_

---

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