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 affective 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" didn't work. Half will be put on a regimen containing a boosted protease inhibitor 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 two different combination antiretroviral regimens as second-line therapy for control of HIV infection after first-line regimen failure in resource-rich and -limited settings |
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| What is this trial studying? | Treatment strategy |
| Start date: | Early to mid 2009 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. |
| Who can enrol in this trial? | You may be eligible to participate in this trial if you meet the following criteria:
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| Can I access this treatment other than by enrolling in this trial? | Raltegravir is listed on PBS from 1 July 2008 |
| Keywords: | first-line therapy, non-nucleosides, nucleosides, protease inhibitors, raltegravir |
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.
- 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
- Call the Treataware info line if you need further advice
This factsheet, produced by Positive Life NSW, provides you with information and some questions to ask if you are considering participating in a clinical trial.