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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01384682
Registration number
NCT01384682
Ethics application status
Date submitted
28/06/2011
Date registered
29/06/2011
Date last updated
20/01/2016
Titles & IDs
Public title
Maraviroc Switch Collaborative Study
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Scientific title
Randomised, Openlabel Study Evaluating Efficacy and Safety of Maraviroc as a Switch for Either NRTI or 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 cART
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Secondary ID [1]
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2011-01-MAR
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Universal Trial Number (UTN)
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Trial acronym
MARCH
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
HIV
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Maraviroc
No Intervention: No change - continue their current cART regimen
Active Comparator: Replace N(t)RTI drugs with Maraviroc - Replace N(t)RTI drugs with MVC at a dose of 150mg bid (MVC 300mg bid can be used at the discretion of the Investigator if the PI/r is fosamprenavir/r) and continue the PI/r
Active Comparator: Replace PI/r drugs with Maraviroc - Replace PI/r drugs with MVC at a dose of 300mg bid and continue 2N(t)RTI.
Treatment: Drugs: Maraviroc
Maraviroc is a marketed drug for the treatment of HIV-infection. Maraviroc will be supplied in two different oral dose forms, 150mg and 300mg given twice a day. The drug will be dosed according to the recommendations in the product label i.e. with PI/r the dose is 150mg bid except, Maraviroc 300mg bid can be used at the discretion of the investigator if the PI/r is fosamprenavir/r; those randomised to the 2N(t)RTI arm, will receive Maraviroc 300mg bid. Patients randomised to receive Maraviroc will be provided with bottles of Maraviroc which contain a 30-day supply.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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The comparison of the switch arms to control arm of proportions of participants with HIV RNA <200 copies/mL 48 weeks after randomisation.
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Assessment method [1]
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Timepoint [1]
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48 weeks after randomization
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Secondary outcome [1]
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Virological endpoints: proportion of participants with plasma HIV-1 RNA<50 copies/ml
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Assessment method [1]
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A number of secondary endpoints will be examined at or through to week 48 in this protocol. These will include, but not be limited to the following:
Virologic; Immunologic and biomarkers; Clinical; Metabolic and body composition; Safety; Adherence; Quality of Life and Resistance endpoints.
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Timepoint [1]
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48 weeks from randomization
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Eligibility
Key inclusion criteria
- Documented HIV-1 infection by a licensed diagnostic test at any time prior to study
entry
- Age >18 years
- HIV-1 RNA <200 copies/mL plasma for at least 24 weeks
- Stable (>24 weeks) ART including two N(t)RTIs and a PI/r
- No evidence of any primary HIV genotypic mutations in HIV reverse transcriptase or
protease for all patients with available resistance testing results conducted prior to
cART and/or during viral rebound/failure
- Provision of written, informed consent.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- CXCR4 or CCR5/CXCR4 dual tropic HIV tropism or a non-reportable tropism result based
on assessment using proviral DNA
- Anticipated need to modify current cART regimen for toxicity management in the next 6
months
- The following laboratory criteria,
1. absolute neutrophil count (ANC) <750 cells/µL
2. haemoglobin <8.0 g/dL
3. platelet count <50,000 cells/µL
4. serum AST, ALT >5 x upper limit of normal (ULN)
- Active hepatitis B co-infection
- Pregnant women or nursing mothers
- Current use of any prohibited medications as described in product specific
information.
- Hypersensitivity to soy or peanuts
- Acute therapy for serious infection or other serious medical illness (in the judgement
of the site Principal Investigator) requiring systemic treatment and/or
hospitalisation
- Use of immunomodulators (e.g. systemic corticosteroids, recombinant interleukin-2,
interferon) within 30 days prior to screening
- Patients with current alcohol or illicit substance use that in the opinion of the site
Principal Investigator would conflict with any aspect of the conduct of the study
- Patients unlikely to be able to remain in follow-up for the protocol-defined period
- Prisoners or subjects who are compulsorily detained (involuntary incarcerated).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2015
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Sample size
Target
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Accrual to date
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Final
399
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Holdsworth House Medical Practice - Sydney
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Recruitment hospital [2]
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St. Vincent's Hospital - Sydney
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Royal Prince Alfred Hospital - Sydney
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Westmead Hospital - Sydney
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Gladstone Road Medical Centre - Bisbane
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Brisbane Sexual Health and HIV Service (formerly AMU) - Brisbane
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Nambour General Hospital - Nambour
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O'Brien Street Practice - Adelaide
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Alfred Hospital - Melbourne
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Recruitment hospital [10]
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Monash Medical Centre - Melbourne
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Recruitment postcode(s) [1]
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2010 - Sydney
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Recruitment postcode(s) [2]
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2050 - Sydney
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Recruitment postcode(s) [3]
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2145 - Sydney
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Recruitment postcode(s) [4]
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4101 - Bisbane
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Recruitment postcode(s) [5]
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4000 - Brisbane
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Recruitment postcode(s) [6]
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4560 - Nambour
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Recruitment postcode(s) [7]
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5000 - Adelaide
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Recruitment postcode(s) [8]
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3004 - Melbourne
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Recruitment postcode(s) [9]
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3168 - Melbourne
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Recruitment outside Australia
Country [1]
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Argentina
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State/province [1]
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Ciudad de Buenos Aires
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Argentina
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Provincia de Buenos Aires
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Argentina
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Provincia de Santa Fe
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Argentina
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Buenos Aires
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Argentina
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Cordoba
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Canada
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Alberta
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Canada
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Ontario
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Canada
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Quebec
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Chile
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Santiago RM
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France
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Orleans
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Germany
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Frankfurt am Main
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Germany
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Berlin
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Germany
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Bonn
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Germany
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Cologne
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Germany
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Düsseldorf
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Germany
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Hannover
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Ireland
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Dublin
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Japan
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Nagoya
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Mexico
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Jalisco
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Mexico
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Leon
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Mexico
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Mexico City
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Poland
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Warsaw
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Spain
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Catalonia
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Spain
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Madrid
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Spain
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Malaga
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Spain
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Seville
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Spain
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Valencia
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Thailand
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Bangkok
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United Kingdom
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Lothian
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United Kingdom
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Sussex
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United Kingdom
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Warwickshire
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United Kingdom
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London
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Funding & Sponsors
Primary sponsor type
Other
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Name
Kirby Institute
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Other collaborator category [1]
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Commercial sector/Industry
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ViiV Healthcare
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Pfizer
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Ethics approval
Ethics application status
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Summary
Brief summary
MARCH is an international, multicentre trial planning to enroll 380 HIV-1 infected patients
who are currently on 2N(t)RTI + PI/r regimen and virologically suppressed. Participants will
be randomized (1:2:2) to one of three treatment groups: to continue their current treatment
regimen, maraviroc dose at 150 mg twice daily with PI/r, or maraviroc at 300 mg twice daily
with 2N(t)RTI. As the participants population have HIV RNA <200 copies/mL, the phenotypic
assessment of tropism cannot be used to determine tropism, instead we will employ the
genotypic assessment of tropism by sequencing the V3 loop of the HIV envelope. The main aim
of this study is to investigate whether switching to maraviroc, in combination with either
RTI or PI/r, is as good at keeping the HIV viral load undetectable as the combination of RTI
with PI/r. The other aim is to see if switching to these combinations with maraviroc will
improve some of the side effects that can be seen when people take combination therapy
including RTI and PI/r.
The study hypothesis is that in stable, virologically suppressed (plasma HIV-RNA <200
copies/mL) patients with no history of prior virological failure, a switch to either MVC
dosed at 300mg twice daily (bid) combined with the same 2N(t)RTI backbone regimen or MVC
dosed at 150mg twice daily (bid) with the current PI/r (or 300mg bid at the discretion of the
investigator if the PI/r is fosamprenavir/r) provides similar (non-inferior) antiretroviral
efficacy compared to continuation of the current 2N(t)RTI + PI/r regimen.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01384682
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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David A Cooper, AO
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Address
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Kirby Institute, University of New South Wales
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01384682
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