This trial has not yet started – enrolment for this trial has not yet commenced. Depending on eligibility, you may be able to enrol in this trial at a later date.
About this trial
UPDATE February 2010 - Recruitment about to start
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 trialA clinical trial is a research study to answer specific questions about vaccines or new therapies or new ways of using known treatments. Clinical trials are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people. Trials are in four phases: Phase I tests a new drug or treatment in a small group; Phase II expands the study to a larger group of people; Phase III expands the study to an even larger group of people; and Phase IV takes place after the drug or treatment has been licensed and marketed. 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 |
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| What is this trial studying? | Treatment strategy |
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| Start date: | Early Januarary 2010 This may be the proposed or expected start date for trials which have not yet started. |
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| 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. |
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| How long is this trial planned to go for? | Participants in this trial will be asked to follow the treatment strategy for 96 weeks. |
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| Links to further information: | |
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| 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.
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| Tags: | first-line therapy, salvage therapy |
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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.
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