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TMC114 (darunavir)

Clinical trial • Concluded • 5 May 2008
This trial is concluded. This means the trial has been completed. When the results of the trial have been made public, they will be summarised in the 'outcomes' section of this page. You cannot 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 trialA clinical trial is a research study to answer specific questions about vaccines or new therapies or new ways of using known treatments. Clinical trials are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people. Trials are in four phases: Phase I tests a new drug or treatment in a small group; Phase II expands the study to a larger group of people; Phase III expands the study to an even larger group of people; and Phase IV takes place after the drug or treatment has been licensed and marketed. 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 – ritonavir, darunavir
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.
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[Pharmaceutical Benefits Scheme] The federal government program which subsidises medication costs in Australia. Anti-HIV drugs are part of a special part of the PBS called Section 100 (S100) which is used for expensive, highly specialised drugs..

Tags:darunavir, optimised background regimens

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.

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, read our background information.
  • Email NAPWA if you have any questions or comments about this trial
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This Clinical trial was first published on 5 May 2008 — more than one year ago.

While the content of this clinical trial was checked for accuracy at the time of publication, NAPWA recommends checking to determine whether the information is the most up-to-date available, especially when making decisions which may affect your health.

This article may contain medical information. NAPWA makes every reasonable effort to ensure the information on this website is accurate, reliable and up-to-date, including obtaining technical reviews by medically-qualified reviewers, however the authors of information on this website are not qualified to give medical advice, except where explicitly stated.

The content of this website is intended to support, not replace, the relationship between people living with HIV/AIDS and their medical advisers, and is not intended as a substitute for medical advice.

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