Treataware

TMC114 (darunavir)

This trial is enrolling now. Depending on eligibility and available places in your area, you may be able to enrol in this trial.

About this trial

This study is testing whether taking 800mg of darunavir once-a-day is as effective as taking 600mg of darunavir twice-a-day. (Both doses will be boosted with 100mg of ritonavir).

Participants will also take an individually selected optimised background regimen. This trial is looking for people who are currently on treatments.

Official title:A Randomized, Open-Label Trial to Compare the Efficacy, Safety and Tolerability of DRV/Rtv (800mg/100mg) q.d Versus DRV/Rtv (600mg/100mg) b.i.d in Early Treatment-Experienced HIV-1 Infected Subjects.
What is this trial studying?Treatment strategy
Start date:September 2007

This may be the proposed or expected start date for trials which have not yet started.

How many participants will this trial enrol?612

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 4 weeks.
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
  • Currently taking HIV treatments
  • Viral load at least 1000 copies/ml
  • Need to have been on a stable antiretroviral regimen for at least 3 months
You will not be eligible to participate in this trial if you meet any of the following criteria:
  • Previous or current use of enfuvirtide, tipranavir and/or darunavir
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.
Links to further information:
Can I access this treatment other than by enrolling in this trial?

Darunavir and ritonavir are both available in Australia through the PBS.

Keywords:darunavir, optimised background regimens, ritonavir

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.
  • Call the Treataware info line if you need further advice
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This information was retrieved from the Treataware website (www.treataware.info) on 19 Nov 2008. For further information, please consult the website or call the NAPWA office on 02 8568 0300.