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Second line

Clinical trial • Enrolling • 26 June 2008
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

A treatment regimen consisting of one non-nucleoside (1NNRTI) and two nucleosides (2NRTIs) has become the internationally accepted first-line therapy of choice. But effective as the combination is, it doesn't work for everyone. And those it fails need a reliable back-up. At the moment there is no "internationally accepted" second-line.

This trial will enrol people in both resource-limited and resource-rich countries (including Australia) whose first-line "1NNRTI+2NRTIs" ceased to work. Half will be put on a regimen containing a boosted protease inhibitorA type of anti-HIV drug that works by preventing the production of an enzyme, protease, that HIV needs to replicate. plus 2NRTIs. The other half will be on a boosted protease inhibitor plus raltegravir (from the new drug class of integrase inhibitors).

Investigators will then be able to assess which of these "second-line" combinations is safer, easier to take and better at controlling HIV.

Background information

A reliable and robust second-line treatment option is vital, particularly for those living with HIV in resource poor settings. CD4 counts and physical diagnosis are often the only monitoring methods available. By the time it has been established that the first-line therapy has failed, the situation is often life-threatening and so it is imperative that the second-line does not fail.

Official title:A Randomised Open-label Study Comparing the Safety and Efficacy of Ritonavir Boosted Lopinavir and 2-3N(t)RTI Backbone Versus Ritonavir Boosted Lopinavir and Raltegravir in Participants Virologically Failing First-line NNRTI/2N(t)RTI Therapy
What is this trial studying?Treatment strategy – raltegravir
Start date:Early Januarary 2010

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

How many participants will this trial enrol?480

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 follow the treatment strategy for 96 weeks.
Links to further information:
Can I access this treatment other than by enrolling in this trial?

All drugs being trialled are currently 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.

Tags:first-line therapy, salvage therapy

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
  • Have taken HIV treatments in the past
  • must have failed a first-line therapy containing one NRTI plus two NNRTIs, no prior exposure to protease inhibitors or integrase inhibitors
You will not be eligible to participate in this trial if you meet any of the following criteria:
  • You must not have hepatitis B (HBV)

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 26 June 2008 — more than three years ago.

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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