About this trial
The STEAL study is comparing two different 'fixed-dose combination' treatments. These are: abacavir combined with lamivudine - marketed in Australia as Kivexa -and tenofovir combined with emtricitabine - marketed as Truvada.
Both treatments are taken in combination with other antiretrovirals from different classes. The study will compare the pills for safety and for effectiveness against HIV.
The study is due for completion in August 2008.
Background information
Fixed-dose combination pills, where two or more separate medications are combined in one pill, are popular with HIV positive people and their doctors because they are simpler to take.
Abacavir/lamivudine and tenofovir/emtricitabine are the first two fixed dose combinations approved in Australia. However, like all HIV antiretroviral medications, they may have side effects and problems in some people.
STEAL is looking at both combinations used with antiretrovirals from other classes (e.g. a protease inhibitor or non-nucleoside reverse transcriptase inhibitor), and aims to assess whether both drugs are equally effective against HIV, as well as comparing them for their rates of side effects or other problems.
| Official title: | A randomised open-label trial to assess the safety and efficacy of switching to fixed-dose tenofovir-emtricitabine or abacavir-lamivudine: the STEAL study |
|---|---|
| What is this trial studying? | Existing drug |
| Start date: | June 2006 This may be the proposed or expected start date for trials which have not yet started. |
| How many participants will this trial enrol? | 360 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. |
| Who can enrol in this trial? | You may be eligible to participate in this trial if you meet the following criteria:
|
| Links to further information: | |
| Can I access this treatment other than by enrolling in this trial? | Kivexa and Truvada are licensed HIV therapies available on prescription and subsidised through Section 100 of the Pharmaceutical Benefits Scheme |
| Keywords: | abacavir, emtricitabine, fixed-dose combinations, lamivudine, tenofovir |
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, 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 Backgrounder looks at the science behind clinical trials and the reason why controlled scientific experiments are needed to answer scientific questions.