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MARCH

Clinical trial • Enrolling • 18 October 2011
This trial is enrolling now. Depending on eligibility and available places in your area, you may be able to enrol in this trial.

About this trial

MARCH is an international, multicentre trial enrollingThe act of signing up participants into a study. Generally this process involves evaluating a participant with respect to the eligibility criteria of the study and going through the informed consent process. PLHIVPerson (or people) Living with HIV. This term is now preferred over the older PLWHA. who are currently virologically suppressed on a regimen comprising of two nucleoside/nucleotide reverse transcriptase inhibitors (2NRTI) plus a ritonavir-boosted protease inhbitor (PIA type of anti-HIV drug that works by preventing the production of an enzyme, protease, that HIV needs to replicate./r). Participants will be randomisedA method based on chance by which study participants are assigned to a treatment group. Randomization minimizes the differences among groups by equally distributing people with particular characteristics among all the trial arms. The researchers do not know which treatment is better. From what is known at the time, any one of the treatments chosen could be of benefit to the participant to one of three treatment groups: to continue their current treatment regimen; to start taking maraviroc dose at 150 mg twice daily plus a PI/r; or to start taking maraviroc at 300 mg twice daily plus 2NRTI.

The main aim of this study is to investigate whether switching to maraviroc plus 2NRTI or maraviroc plus PI/r is as good at keeping the viral loadA measurement of the quantity of HIV RNA in the blood. Viral load blood test results are expressed as the number of copies (of HIV) per milliliter of blood plasma. undetectable as the combination of 2NRTI + 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 a combination of 2NRTI + PI/r.

The study hypothesisA supposition or assumption advanced as a basis for reasoning or argument, or as a guide to experimental investigation. is that in stable, virologically suppressed people with no history of prior virological failure, a switch to maraviroc at either dose combined with either backbone regimen will provide similar antiretroviralA medication or other substance which is active against retroviruses such as HIV. efficacy(Of a drug or treatment). The maximum ability of a drug or treatment to produce a result regardless of dosage. A drug passes efficacy trials if it is effective at the dose tested and against the illness for which it is prescribed. In the standard procedure, Phase II clinical trials gauge efficacy, and Phase III trials confirm it. compared to continuation of the current regimen.

Official title:A randomised, open-label study to evaluate the efficacy and safety of maraviroc (MVC) as a switch for either nucleoside or nucleotide analogue reverse transcriptase inhibitors (N(t)RTI) or boosted protease inhibitors (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 combination antiretroviral therapy (cART)
What is this trial studying?Existing drug – maraviroc
Start date:26/08/2011

This may be the proposed or expected start date for trials which have not yet started.

How many participants will this trial enrol?560

The exact number of participants may be lower or slightly higher than this. Some trials also have specific quotas for participants from each state, city or clinic.

How long is this trial planned to go for?Participants in this trial will be asked to take the trial drug for 48 weeks. Following the conclusion of the trial, participants will be followed up for a further 48 weeks.
Links to further information:
Can I access this treatment other than by enrolling in this trial?

Maraviroc is approved in Australia and available on the PBS[Pharmaceutical Benefits Scheme] The federal government program which subsidises medication costs in Australia. Anti-HIV drugs are part of a special part of the PBS called Section 100 (S100) which is used for expensive, highly specialised drugs.

Who can enrol in this trial?

You may be eligible to participate in this trial if you meet the following criteria:

  • At least 18 years old
  • Currently taking HIV treatments
  • Viral load below 200 copies/ml
You will not be eligible to participate in this trial if you meet any of the following criteria:
  • You must not have multiple HIV drug resistance
  • You must not have hepatitis B (HBV)
  • Pregnant, or considering becoming pregnant during the course of the trial

This is a summary of key inclusion and exclusion criteria for this trial. There may be other criteria which may exclude some people from participation in this trial. Some laboratory tests may also be required. Consult your doctor, or view the trial protocol or informed consent documentation to see the full range of exclusion and inclusion criteria.

If you are interested in enrolling in this trial

Before making the decision to participate in any clinical trial, NAPWA recommends that you discuss the potential benefits and risks of participation with your treating doctor. Your doctor can also provide advice about your eligibility to participate in the trial.

While NAPWA has taken every care to compile the information on this page and to keep it up-to-date, we cannot guarantee its correctness and completeness.

  • You can print this page to take it with you to the doctor – just use your browser's 'print' function.
  • Before making the decision to participate in any clinical research, read our background information.
  • Email NAPWA if you have any questions or comments about this trial
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This Clinical trial was first published on 18 October 2011.

While the content of this clinical trial was checked for accuracy at the time of publication, NAPWA recommends checking to determine whether the information is the most up-to-date available, especially when making decisions which may affect your health.

This article may contain medical information. NAPWA makes every reasonable effort to ensure the information on this website is accurate, reliable and up-to-date, including obtaining technical reviews by medically-qualified reviewers, however the authors of information on this website are not qualified to give medical advice, except where explicitly stated.

The content of this website is intended to support, not replace, the relationship between people living with HIV/AIDS and their medical advisers, and is not intended as a substitute for medical advice.

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