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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Sex
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
1/08/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2015
Sample size
Target
Accrual to date
Final
399
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
Government body
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01384682