This trial is fully enrolled. This means that all of the available places on the trial have been filled. You cannot enrol in 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.
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
tx_strategy – raltegravir
Early Januarary 2010 (This may be the proposed or expected start date for trials which have not yet started.)
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.)
Participants in this trial will be asked to follow the treatment strategy for 96 weeks.
You may be eligible to participate in this trial if you meet the following criteria:
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.
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.
Before making the decision to participate in any clinical research, visit the NAPWA website for background information on participating in clinical research.
Contact NAPWA if you have any questions or comments about this trial.