Maraviroc Switch Collaborative Study (MARCH)
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Purpose
MARCH is an international, multicentre trial planning to enroll 560 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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV |
Drug: Maraviroc |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- 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 ] [ Designated as safety issue: Yes ]
- Virological endpoints: proportion of participants with plasma HIV-1 RNA<50 copies/ml [ Time Frame: 48 weeks from randomization ] [ Designated as safety issue: Yes ]
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.
| Estimated Enrollment: | 560 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Drug: 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.
|
|
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.
|
Drug: 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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
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,
- absolute neutrophil count (ANC) <750 cells/µL
- haemoglobin <8.0 g/dL
- platelet count <50,000 cells/µL
- 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).
Contacts and Locations| Contact: Sarah L Pett, FRACP, FRCPE,PhD | +61293850900 | spett@kirby.unsw.edu.au |
Show 58 Study Locations| Principal Investigator: | David A Cooper, AO | Kirby Institute, University of New South Wales |
More Information
Additional Information:
No publications provided
| Responsible Party: | Kirby Institute |
| ClinicalTrials.gov Identifier: | NCT01384682 History of Changes |
| Other Study ID Numbers: | 2011-01-MAR |
| Study First Received: | June 28, 2011 |
| Last Updated: | December 7, 2012 |
| Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Australia: Department of Health and Ageing Therapeutic Goods Administration Canada: Health Canada Chile: Ministry of Health France: L’Agence nationale de sécurité du médicament et des produits de santé Germany: Ministry of Health Ireland: Irish Medicines Board Japan: Ministry of Health, Labor and Welfare Mexico: Ministry of Health Spain: Agencia Española de Medicamentos y Productos Sanitarios Thailand: Ministry of Public Health United Kingdom: Medicines and Healthcare Products Regulatory Agency Poland: CEBK |
ClinicalTrials.gov processed this record on May 23, 2013