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Trial record 6 of 37 for:    " June 20, 2012":" July 20, 2012"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]
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MARCH Central Nervous System Substudy

This study is currently recruiting participants.
Verified May 2013 by Kirby Institute
Sponsor:
Information provided by (Responsible Party):
Kirby Institute
ClinicalTrials.gov Identifier:
NCT01637233
First received: June 27, 2012
Last updated: May 29, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention
HIV-1 Infection
 Drug: Arm 1 TNucleotide Analogue Reverse Transcriptase Inhibitors and Boosted Protease Inhibitors
Drug: Arm 2 Maraviroc and Protease Inhibitors
Drug: Arm 3 Maraviroc and Nucleotide Analogue Reverse Transcriptase Inhibitors

Study Type: Observational
Study Design: Time Perspective: Prospective
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).

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Kirby Institute:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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:
  • 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 ] [ Designated as safety issue: Yes ]

    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


Biospecimen Retention:   Samples Without DNA

plasma and CSF


Estimated Enrollment: 50
Study Start Date: June 2012
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
NRTI + PI
This is the randomisation of the main study, Arm 1
 Drug: Arm 1 TNucleotide Analogue Reverse Transcriptase Inhibitors and Boosted Protease Inhibitors
NRTI+PI
Other Names:
  • tenofovir
  • emtricitabine
  • zidovudine
  • lamivudine
  • abacavir
  • Ritonavir
  • lopinavir
  • darunavir
  • atazanavir
  • fosamprenavir
maraviroc + PI
this is the randomisation of the main study, Arm 2
 Drug: Arm 2 Maraviroc and Protease Inhibitors
maraviroc + PI
Other Names:
  • maraviroc
  • Ritonavir
  • lopinavir
  • darunavir
  • atazanavir
  • fosamprenavir
maraviroc + NRTI
this is the randomisation of the main study, Arm 3
 Drug: Arm 3 Maraviroc and Nucleotide Analogue Reverse Transcriptase Inhibitors
maraviroc + NRTI
Other Names:
  • maraviroc
  • tenofovir
  • emtricitabine
  • zidovudine
  • lamivudine
  • abacavir

Detailed Description:

this is detailed above, this is a substudy of MARCH

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

participants in the MARCH main study who are eligible for the CNS substudy and provide written informed consent for participation

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01637233

Contacts
Contact: Natalie Espinosa, BSc 61293850900 nespinosa@kirby.unsw.edu.au
Contact: Sarah L Pett, FRACP, FRCPE, PhD 61293850900 spett@kirby.unsw.edu.au

Locations
Argentina
Hospital Profesor Alejandro Posadas Not yet recruiting
Buenos Aires, Provincia de Buenos Aires, Argentina, 1684
Contact: Hector Laplume, M.D.     54-11-44696972     hlaplume@sPeedy.com.ar    
Contact: Lucia Daciuk, M.D     54-11-44696972     luciadaciuk@hotmail.com    
Hospital Ramos Mejía Recruiting
Buenos Aires, Argentina, C1221ADC
Contact: Marcelo Losso, M.D.     5411 4931 5252     mlosso@hivramos.org.ar    
Contact: Guillermo Viloria, M.D.     5411 4931 5252     gviloria@hivramos.org.ar    
Hospital Italiano de Buenos Aires Recruiting
Buenos Aires, Argentina, C1181ACH
Contact: Marisa del Luján Sánchez, M.D.     54 11 49590393     marisa.sanchez@hospitalitaliano.org.ar    
Contact: Mariana De Paz Sierra, M.D.     54 11 49590393     mariana.depaz@hospitalitaliano.org.ar    
Fundación IDEAA Recruiting
Buenos Aires, Argentina, C1405CKC
Contact: Norma Porteiro, M.D     5411 4901 7133     normaporteiro@yahoo.com.ar    
Contact: Cecilia Vilas     5411 4901 7133     ideaa@fundacionideaa.org.ar    
CAICI Not yet recruiting
Rosario, Argentina
Contact: Sergio Lupo, MD         drsergiolupo@gmail.com    
Australia, New South Wales
St. Vincent's Hospital Recruiting
Sydney, New South Wales, Australia, 2010
Contact: David A Cooper, MD, DSc     61293850900     dcooper@kirby.unsw.edu.au    
Mexico
Hospital Civil de Guadalajara Not yet recruiting
Guadalajara, Mexico
Contact: Jaime Andrade-Villanueva, MD         jandradev@msn.com    
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán Not yet recruiting
Mexico City, Mexico
Contact: Juan Sierra Madero, MD         jsmadero@yahoo.com    
Thailand
Chulalongkorn University Hospital Recruiting
Bangkok, Thailand, 10330
Contact: Kiat Ruxrungtham, M.D.     66-2252-8181-9 ext 3596     kiat.r@chula.ac.th    
Contact: Wirach Maek-a-nantawat,, M.D.     66-2-6523040 ext 169     wirach.m@hivnat.org;    
United Kingdom
Brighton & Sussex University NHS Trust Recruiting
Brighton, Sussex, United Kingdom, BN21ES,
Contact: Amanda Clarke, M.D.         amanda.clarke@bsuh.nhs.uk    
Contact: Nicky Perry     01273 523079     nicky.perry@bsuh.nhs.uk;    
Imperial Healthcare, St. Mary's Hospital Recruiting
London, United Kingdom, W2
Contact: Alan Winston, M.D.     44 (0)20 3312 1603     a.winston@imperial.ac.uk    
Contact: Scott Mullaney     44 (0)20 3312 1464     s.mullaney@imperial.ac.uk    
Sponsors and Collaborators
Kirby Institute
Investigators
Principal Investigator: Alan Winston, MD Imperial Healthcare, London, UK
  More Information

No publications provided

Responsible Party: Kirby Institute
ClinicalTrials.gov Identifier: NCT01637233     History of Changes
Other Study ID Numbers: MARCH-Kirby CNS, 2011-002107-15
Study First Received: June 27, 2012
Last Updated: May 29, 2013
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Thailand: Ministry of Public Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Kirby Institute:
HIV-1 infection
neurocognitive function
switch study

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Protease Inhibitors
Ritonavir
Lopinavir
Atazanavir
Fosamprenavir
Darunavir
 Zidovudine
Lamivudine
Reverse Transcriptase Inhibitors
Tenofovir
Abacavir
Emtricitabine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites
Nucleic Acid Synthesis Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013