Maraviroc Switch Collaborative Study

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01384682
• Date of registration: 28/06/2011
• Primary sponsor: Kirby Institute
• Public title: Maraviroc Switch Collaborative Study MARCH
• 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
• Date of first enrolment: August 2011
• Target sample size: 560
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01384682
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Argentina, Australia, Canada, Chile, France, Germany, Ireland, Japan, Mexico, Peru, Spain, Thailand, United Kingdom

Contacts

• Name: Sarah L Pett, FRACP, FRCPE,PhD

• Name: David A Cooper, AO
• Affiliation: Kirby Institute, University of New South Wales

Key inclusion & exclusion criteria

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,

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).



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

HIV

Intervention(s)

Drug: Maraviroc

Primary Outcome(s)

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]

Secondary Outcome(s)

Virological endpoints: proportion of participants with plasma HIV-1 RNA<50 copies/ml [Time Frame: 48 weeks from randomization]

Secondary ID(s)

2011-01-MAR

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Pfizer

ViiV Healthcare