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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
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
Secondary ID [1] 0 0
2011-01-MAR
Universal Trial Number (UTN)
Trial acronym
MARCH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The comparison of the switch arms to control arm of proportions of participants with HIV RNA <200 copies/mL 48 weeks after randomisation.
Timepoint [1] 0 0
48 weeks after randomization
Secondary outcome [1] 0 0
Virological endpoints: proportion of participants with plasma HIV-1 RNA<50 copies/ml - 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.
Timepoint [1] 0 0
48 weeks from randomization

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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Holdsworth House Medical Practice - Sydney
Recruitment hospital [2] 0 0
St. Vincent's Hospital - Sydney
Recruitment hospital [3] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment hospital [4] 0 0
Westmead Hospital - Sydney
Recruitment hospital [5] 0 0
Gladstone Road Medical Centre - Bisbane
Recruitment hospital [6] 0 0
Brisbane Sexual Health and HIV Service (formerly AMU) - Brisbane
Recruitment hospital [7] 0 0
Nambour General Hospital - Nambour
Recruitment hospital [8] 0 0
O'Brien Street Practice - Adelaide
Recruitment hospital [9] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [10] 0 0
Monash Medical Centre - Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Sydney
Recruitment postcode(s) [2] 0 0
2050 - Sydney
Recruitment postcode(s) [3] 0 0
2145 - Sydney
Recruitment postcode(s) [4] 0 0
4101 - Bisbane
Recruitment postcode(s) [5] 0 0
4000 - Brisbane
Recruitment postcode(s) [6] 0 0
4560 - Nambour
Recruitment postcode(s) [7] 0 0
5000 - Adelaide
Recruitment postcode(s) [8] 0 0
3004 - Melbourne
Recruitment postcode(s) [9] 0 0
3168 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Ciudad de Buenos Aires
Country [2] 0 0
Argentina
State/province [2] 0 0
Provincia de Buenos Aires
Country [3] 0 0
Argentina
State/province [3] 0 0
Provincia de Santa Fe
Country [4] 0 0
Argentina
State/province [4] 0 0
Buenos Aires
Country [5] 0 0
Argentina
State/province [5] 0 0
Cordoba
Country [6] 0 0
Canada
State/province [6] 0 0
Alberta
Country [7] 0 0
Canada
State/province [7] 0 0
Ontario
Country [8] 0 0
Canada
State/province [8] 0 0
Quebec
Country [9] 0 0
Chile
State/province [9] 0 0
Santiago RM
Country [10] 0 0
France
State/province [10] 0 0
Orleans
Country [11] 0 0
Germany
State/province [11] 0 0
Frankfurt am Main
Country [12] 0 0
Germany
State/province [12] 0 0
Berlin
Country [13] 0 0
Germany
State/province [13] 0 0
Bonn
Country [14] 0 0
Germany
State/province [14] 0 0
Cologne
Country [15] 0 0
Germany
State/province [15] 0 0
Düsseldorf
Country [16] 0 0
Germany
State/province [16] 0 0
Hannover
Country [17] 0 0
Ireland
State/province [17] 0 0
Dublin
Country [18] 0 0
Japan
State/province [18] 0 0
Nagoya
Country [19] 0 0
Mexico
State/province [19] 0 0
Jalisco
Country [20] 0 0
Mexico
State/province [20] 0 0
Leon
Country [21] 0 0
Mexico
State/province [21] 0 0
Mexico City
Country [22] 0 0
Poland
State/province [22] 0 0
Warsaw
Country [23] 0 0
Spain
State/province [23] 0 0
Catalonia
Country [24] 0 0
Spain
State/province [24] 0 0
Madrid
Country [25] 0 0
Spain
State/province [25] 0 0
Malaga
Country [26] 0 0
Spain
State/province [26] 0 0
Seville
Country [27] 0 0
Spain
State/province [27] 0 0
Valencia
Country [28] 0 0
Thailand
State/province [28] 0 0
Bangkok
Country [29] 0 0
United Kingdom
State/province [29] 0 0
Lothian
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Sussex
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Warwickshire
Country [32] 0 0
United Kingdom
State/province [32] 0 0
London

Funding & Sponsors
Primary sponsor type
Other
Name
Kirby Institute
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
ViiV Healthcare
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
Pfizer
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT01384682
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David A Cooper, AO
Address 0 0
Kirby Institute, University of New South Wales
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications