HIV-1 InfectionNCT01637233
MARCH Central Nervous System Substudy
An observational study of HIV-1 Infection, run by Kirby Institute at 6 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1 Infection
- What is being tested?
- Arm 1 TNucleotide Analogue Reverse Transcriptase Inhibitors and Boosted Protease Inhibitors, Arm 2 Maraviroc and Protease Inhibitors and Arm 3 Maraviroc and Nucleotide Analogue Reverse Transcriptase Inhibitors
- How many people
- 28 participants
- Where
- 6 sitesin 3 countries
- Study dates
- Jun 2012to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: participants in the MARCH main study who are eligible for the CNS substudy and provide written informed consent for participation
Who may be able to join
- 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
Who cannot join
- Pre-existing CNS diseases
- Recent head injury (past three months)
- Current history of major depression or psychosis
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Argentina3 sites
Fundación IDEAA
Buenos Aires, Buenos Aires, C1405CKC
Hospital Ramos Mejía
Buenos Aires, C1221ADC
CAICI
Rosario
United Kingdom2 sites
Brighton & Sussex University NHS Trust
Brighton, Sussex, BN21ES,
Imperial Healthcare, St. Mary's Hospital
London, W2
About this study
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).
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:
Read more
- Neurocognitive function as assessed by a computerised testing battery called CogState;
- 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.
Read the detailed description
this is detailed above, this is a substudy of MARCH
- Conditions
- HIV-1 Infection
- Being tested
- Arm 1 TNucleotide Analogue Reverse Transcriptase Inhibitors and Boosted Protease Inhibitors, Arm 2 Maraviroc and Protease Inhibitors, Arm 3 Maraviroc and Nucleotide Analogue Reverse Transcriptase Inhibitors
- Keywords
- HIV-1 infection, neurocognitive function, switch study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm 1 TNucleotide Analogue Reverse Transcriptase Inhibitors and Boosted Protease InhibitorsDrug
Also called tenofovir, emtricitabine, zidovudine, lamivudine
NRTI+PI
Arm 2 Maraviroc and Protease InhibitorsDrug
Also called maraviroc, Ritonavir, lopinavir, darunavir
maraviroc + PI
Arm 3 Maraviroc and Nucleotide Analogue Reverse Transcriptase InhibitorsDrug
Also called maraviroc, tenofovir, emtricitabine, zidovudine
maraviroc + NRTI
| Study group | Role | What they receive |
|---|---|---|
| NRTI + PI | This is the randomisation of the main study, Arm 1 Receives: Drug: Arm 1 TNucleotide Analogue Reverse Transcriptase Inhibitors and Boosted Protease Inhibitors | |
| maraviroc + PI | this is the randomisation of the main study, Arm 2 Receives: Drug: Arm 2 Maraviroc and Protease Inhibitors | |
| maraviroc + NRTI | this is the randomisation of the main study, Arm 3 Receives: Drug: Arm 3 Maraviroc and Nucleotide Analogue Reverse Transcriptase Inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
using CogState testing at 5 timepoints, weeks 0, 12, 24, 48, 96
Measured: 96 weeks
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
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
Measured: 96 weeks
Secondary outcomes (1)
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
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
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirby Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Alan Winston, MD, Principal investigator, Imperial Healthcare, London, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01637233
- Sponsor's protocol ID
- MARCH-Kirby CNS
- Other IDs
- 2011-002107-15
- Status last verified
- Jan 2016
- First submitted
- 27 Jun 2012
- Last updated
- 20 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT01637233
- Acronym / sponsor ID
- MARCH-Kirby CNS
- Conditions
- HIV-1 Infection
- Keywords
- HIV-1 infection, neurocognitive function, switch study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Kirby InstituteOther government
- Study start
- Jun 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 11 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Neurocognitive function as assessed by a computerised testing battery called CogState;
- 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
Study design
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NRTI + PI | – | Drug: Arm 1 TNucleotide Analogue Reverse Transcriptase Inhibitors and Boosted Protease InhibitorsThis is the randomisation of the main study, Arm 1 |
| maraviroc + PI | – | Drug: Arm 2 Maraviroc and Protease Inhibitorsthis is the randomisation of the main study, Arm 2 |
| maraviroc + NRTI | – | Drug: Arm 3 Maraviroc and Nucleotide Analogue Reverse Transcriptase Inhibitorsthis is the randomisation of the main study, Arm 3 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- participants in the MARCH main study who are eligible for the CNS substudy and provide written informed consent for participation
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Pre-existing CNS diseases
- Recent head injury (past three months)
- Current history of major depression or psychosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arm 1 TNucleotide Analogue Reverse Transcriptase Inhibitors and Boosted Protease InhibitorsAlso: tenofovir, emtricitabine, zidovudine, lamivudineNRTI+PI | Drug | NRTI + PI |
| Arm 2 Maraviroc and Protease InhibitorsAlso: maraviroc, Ritonavir, lopinavir, darunavirmaraviroc + PI | Drug | maraviroc + PI |
| Arm 3 Maraviroc and Nucleotide Analogue Reverse Transcriptase InhibitorsAlso: maraviroc, tenofovir, emtricitabine, zidovudinemaraviroc + NRTI | Drug | maraviroc + NRTI |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan Winston, MD principal investigator
Imperial Healthcare, London, UK
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV-1 Infection, run by Kirby Institute at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Argentina, United Kingdom, Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 96 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2016.