Rollover Tipranavir and Ritonavir Trial

This trial is concluded. This means the trial has been completed. The results of the trial are summarised in the 'results' section of this page. You cannot enrol in this trial.

About this trial

This study is testing a combination of tipranavir and ritonavir to see how safe and easy-to-take the drugs are together.

The idea is to combine the two drugs into one pill or 'fixed dose combination' containing 500mg of tipranavir and 200mg of ritonavir which can be taken twice a day along with an optimized background regimen.

Background information

'Fixed-dose combinations' are popular because they can reduce 'pill burden' for the people taking them while increasing 'pill sales' for the companies selling them.

Other licensed fixed-dose combination pills include Combivir (lamivudine/zidovudine), Trizivir (abacavir/lamivudine/zidovudine) and Truvada (tenofovir/emtracitabine).

Official title:

A Long Term Open Label Rollover Trial Assessing the Safety and Tolerability of Combination Tipranavir and Ritonavir Use in HIV-1 Infected Subjects

What is this trial studying?

tx_strategy

How many participants will this trial enrol?

1074 (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 48 weeks. Following the conclusion of the trial, participants will be followed up for a further 48 weeks.

Links to further information:

• http://clinicaltrials.gov/ct2/show/NCT00146328?term=Boehringer+AND+HIV&cntry1=PA%3AAU&rank=1&show_locs=Y#locn

Can I access this treatment other than by enrolling in this trial?

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
• All subjects must have successfully completed participation in a combination tipranavir/ritonavir trial or have confirmed virologic failure in the RESIST trials

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.

Results:

Disclaimer

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.