HIVPhase 4MARCHNCT01384682
Maraviroc Switch Collaborative Study
A Phase 4 study testing Maraviroc in people with HIV, run by Kirby Institute at 51 sites in 13 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- Maraviroc
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 399 participants
- Where
- 51 sitesin 13 countries
- Study dates
- Aug 2011to Dec 2015
- Phase
- Phase 4
- 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
Who may be able to join
- 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.
Who cannot join
- 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,
- absolute neutrophil count (ANC) <750 cells/µL
- haemoglobin <8.0 g/dL
- platelet count <50,000 cells/µL
Show all 16Show fewer
- 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).
Trial locations and contacts
51 sites in 13 countries.
51 sites in 13 countries
Australia10 sites
O'Brien Street Practice
Adelaide, South Australia, 5000
Gladstone Road Medical Centre
Bisbane, Queensland, 4101
Brisbane Sexual Health and HIV Service (formerly AMU)
Brisbane, Queensland, 4000
Alfred Hospital
Melbourne, Victoria, 3004
Monash Medical Centre
Melbourne, Victoria, 3168
Nambour General Hospital
Nambour, Queensland, 4560
Holdsworth House Medical Practice
Sydney, New South Wales, 2010
St. Vincent's Hospital
Sydney, New South Wales, 2010
Royal Prince Alfred Hospital
Sydney, New South Wales, 2050
Westmead Hospital
Sydney, New South Wales, 2145
Argentina8 sites
Fundacion IDEAA
Buenos Aires, Buenos Aires, C1405CKC
FUNCEI
Buenos Aires, Buenos Aires F.D., 1425
Hospital Italiano de Buenos Aires
Buenos Aires, Buenos Aires F.D., C1181ACH
Hospital G de Agudos JM Ramos Mejia
Buenos Aires, Buenos Aires F.D., C1221ADC
Hospital Privado- Centro Medico Cordoba
Córdoba
Hospital Nacional Prof Alejandro Posadas
El Palomar, Buenos Aires, 1684
Hospital Dr Diego Paroissien
Isidro Casanova, Buenos Aires, 1765
CAICI
Rosario, Santa Fe Province, S2000PBJ
Spain8 sites
Hospital Germans Trias i Pujol
Badalona, Catalonia, 08916
Hospital Clínic de Barcelona
Barcelona, Catalonia, 08036
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, 08041
Hospital La Paz,
Madrid, 28046
Hospital Principe de Asturias
Madrid, 28805
Hospital Regional Carlos Haya de Málaga
Málaga, Malaga, 29010
Virgen Del Rocio University Hospital
Seville, 41013
Hospital Universitari i Politecnic La Fe
Valencia, 46026
Germany7 sites
Gemeinschaftspraxis Jessen Jessen Stein
Berlin, State of Berlin, 10777
Dienstleistung centre ID (Baumgarten, MIB medical center for infectious diseases)
Berlin, 13353
University of Bonn, Med J. Immunologische Siudienzenirale
Bonn, 53127
Klinikum der Universitat Zu Koln
Cologne, 50937
Universitätsklinikum Düsseldorf, Klinik für Gastroenterologie, Hepatologie und Infektiologie-MX- Amb
Düsseldorf, 40225
Johann Wolfgang Goethe-University Hospital, Medical HIVCENTER
Frankfurt, Frankfurt Am Main, 60590
Klinik für Immunologie und Rheumatologie, Medzinische Hochschule Hannover
Hanover, 30625
United Kingdom5 sites
Brighton & Sussex University NHS Trust
Brighton, Sussex, BN21ES
Coventry and Warwickshire Partnership Trust
Coventry, Warwickshire, CV 1 4FS
Western General Hospital
Edinburgh, Lothian
St. Mary's Hospital, Imperial College
London, London, W2
St. Thomas's Hospital
London, London
Canada4 sites
Southern Alberta Clinic
Calgary, Alberta, T2R OX7
Clinic Opus/Lori
Montreal, Quebec, H3A 1T1
University Health Network/Toronto General Hospital
Toronto, Ontario, M5G 2N2
Canadian Immunodeficiency Research Collaborative (CIRC) lnc (Maple Leaf Clinic)
Toronto, Ontario, ON M5G 1k2
Mexico3 sites
Hospital Civil de Guadalajara
Guadalajara, Jalisco, 44280
Hospital General de Leon
León, 37320
INCMNSZ
Mexico City
France1 site
Service Maladies infectieuses et Tropicales CHR ORLEANS La SOURCE
Orléans, 45100
Poland1 site
Wojewodzki Szpital Zakazny Centrum Diagnostyki i Terapii AIDS
Warsaw, Warsaw, 01-201
About this study
Official 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
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.
- Conditions
- HIV
- Being tested
- Maraviroc
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MaravirocDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| No change | No intervention | continue their current cART regimen |
| Replace N(t)RTI drugs with Maraviroc | Active comparator | 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 Receives: Drug: Maraviroc |
| Replace PI/r drugs with Maraviroc | Active comparator | Replace PI/r drugs with MVC at a dose of 300mg bid and continue 2N(t)RTI. Receives: Drug: Maraviroc |
What is being measured
The primary outcome is the main question the study is designed to answer.
The comparison of the switch arms to control arm of proportions of participants with HIV RNA <200 copies/mL 48 weeks after randomisation.
Measured: 48 weeks after randomization
Secondary outcomes (1)
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.
Measured: 48 weeks from randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2011 (estimated)
- Study startAug 2011
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIVStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 399 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirby Institute
- Sponsor type
- Other government
- Collaborators
- ViiV Healthcare, Pfizer
- Responsible party
- Sponsor
- Investigators
- David A Cooper, AO, Principal investigator, Kirby Institute, University of New South Wales
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01384682
- Sponsor's protocol ID
- 2011-01-MAR
- Acronym
- MARCH
- Status last verified
- Jan 2016
- First submitted
- 28 Jun 2011
- Last updated
- 20 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pett SL, Amin J, Horban A, Andrade-Villanueva J, Losso M, Porteiro N, Sierra Madero J, Belloso W, Tu E, Silk D, Kelleher A, Harrigan R, Clark A, Sugiura W, Wolff M, Gill J, Gatell J, Fisher M, Clarke A, Ruxrungtham K, Prazuck T, Kaiser R, Woolley I, Arnaiz JA, Cooper D, Rockstroh JK, Mallon P, Emery S; Maraviroc Switch (MARCH) Study Group. Maraviroc, as a Switch Option, in HIV-1-infected Individuals With Stable, Well-controlled HIV Replication and R5-tropic Virus on Their First Nucleoside/Nucleotide Reverse Transcriptase Inhibitor Plus Ritonavir-boosted Protease Inhibitor Regimen: Week 48 Results of the Randomized, Multicenter MARCH Study. Clin Infect Dis. 2016 Jul 1;63(1):122-32. doi: 10.1093/cid/ciw207. Epub 2016 Apr 5.
PubMed 27048747Tu E, Swenson LC, Land S, Pett S, Emery S, Marks K, Kelleher AD, Kaye S, Kaiser R, Schuelter E, Harrigan R; MARCH Laboratory Group and the MARCH Study Group. Results of external quality assessment for proviral DNA testing of HIV tropism in the Maraviroc Switch collaborative study. J Clin Microbiol. 2013 Jul;51(7):2063-71. doi: 10.1128/JCM.00510-13. Epub 2013 Apr 17.
PubMed 23596247
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
- 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
- ClinicalTrials.gov ID
- NCT01384682
- Acronym / sponsor ID
- MARCH / 2011-01-MAR
- Conditions
- HIV
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 399 participants (actual)
- Lead sponsor
- Kirby InstituteOther government
- Collaborators
- ViiV Healthcare, Pfizer
- Study start
- Aug 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 29 Jun 2011 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No change | No intervention | –continue their current cART regimen |
| Replace N(t)RTI drugs with Maraviroc | Active comparator | Drug: MaravirocReplace 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 |
| Replace PI/r drugs with Maraviroc | Active comparator | Drug: MaravirocReplace PI/r drugs with MVC at a dose of 300mg bid and continue 2N(t)RTI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (16 listed)
- 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,
- Active hepatitis B co-infection
- Pregnant women or nursing mothers
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 |
|---|---|---|
| MaravirocMaraviroc 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. | Drug | Replace N(t)RTI drugs with Maraviroc, Replace PI/r drugs with Maraviroc |
Primary outcome
The comparison of the switch arms to control arm of proportions of participants with HIV RNA <200 copies/mL 48 weeks after randomisation.
Time frame: 48 weeks after randomization
1 secondary outcome
Virological endpoints: proportion of participants with plasma HIV-1 RNA<50 copies/ml
Time frame: 48 weeks from randomization
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.
- Derived from this study: PubMed 27048747Pett SL, Amin J, Horban A, Andrade-Villanueva J, Losso M, Porteiro N, Sierra Madero J, Belloso W, Tu E, Silk D, Kelleher A, Harrigan R, Clark A, Sugiura W, Wolff M, Gill J, Gatell J, Fisher M, Clarke A, Ruxrungtham K, Prazuck T, Kaiser R, Woolley I, Arnaiz JA, Cooper D, Rockstroh JK, Mallon P, Emery S; Maraviroc Switch (MARCH) Study Group. Maraviroc, as a Switch Option, in HIV-1-infected Individuals With Stable, Well-controlled HIV Replication and R5-tropic Virus on Their First Nucleoside/Nucleotide Reverse Transcriptase Inhibitor Plus Ritonavir-boosted Protease Inhibitor Regimen: Week 48 Results of the Randomized, Multicenter MARCH Study. Clin Infect Dis. 2016 Jul 1;63(1):122-32. doi: 10.1093/cid/ciw207. Epub 2016 Apr 5.
- Derived from this study: PubMed 23596247Tu E, Swenson LC, Land S, Pett S, Emery S, Marks K, Kelleher AD, Kaye S, Kaiser R, Schuelter E, Harrigan R; MARCH Laboratory Group and the MARCH Study Group. Results of external quality assessment for proviral DNA testing of HIV tropism in the Maraviroc Switch collaborative study. J Clin Microbiol. 2013 Jul;51(7):2063-71. doi: 10.1128/JCM.00510-13. Epub 2013 Apr 17.
- Kirby Institute for infection and immunity in society homepage - click here for more information on the MARCH study.Link provided by the sponsor.
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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.
David A Cooper, AO principal investigator
Kirby Institute, University of New South Wales
51 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Maraviroc in people with HIV, run by Kirby Institute at 51 sites in 13 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 6 inclusion and 16 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 51 sites in Australia, Argentina, Spain, Germany, United Kingdom and 8 more countries. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The comparison of the switch arms to control arm of proportions of participants with HIV RNA <200 copies/mL 48 weeks after randomisation. (time frame: 48 weeks after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01384682, which also lists 2 linked publications.
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.