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TMC125 (etravirine) for people who failed on the DUET studies

Clinical trial • Reported • 10 May 2007
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 trial is providing access to an experimental(Of a drug) Not licensed for use in humans, or as a treatment for a particular condition. Experimental drugs are studied in clinical trials to determine their safety and efficacy, and are sometimes made available via Special Access Schemes prior to their approval. non-nucleoside (NNRTI) called etravirine for people who did not reach undetectable viral loadA measurement of the quantity of HIV RNA in the blood. Viral load blood test results are expressed as the number of copies (of HIV) per milliliter of blood plasma. levels on either of the prior DUET studies. 

The study will look at the long-term safety and tolerability of etravirine as part of an optimised background regimen including darunavir and other drugs chosen by their doctor.

All people will receive etravirine until the drug is approved and commercially available.

Background information

Darunavir is the most recently approved protease inhibitorA type of anti-HIV drug that works by preventing the production of an enzyme, protease, that HIV needs to replicate. in Australia.

Official title:An Open-Label Trial with TMC125 in Patients Who Have Virologically Failed in a DUET Trial (TMC125-C206 or TMC125-C216)
What is this trial studying?New drug – etravirine (TMC-125)
Start date:1 Jun 2006

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

Links to further information:
Related trials:
Can I access this treatment other than by enrolling in this trial?

Etravirine is now available on 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..

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
  • HIV-positive
  • Enrolment in one of two prior randomised trials of TMC125, with at least 24 weeks of the treatment
  • Your viral load did not fall to undetectable levels on this study
You will not be eligible to participate in this trial if you meet any of the following criteria:
  • Experienced severe side effects from TMC125 in the previous study

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:

Conclusion: At 48 weeks, treatment-experienced patients receiving etravirine plus background regimen had statistically superior and durable virologic responses (viral loadA measurement of the quantity of HIV RNA in the blood. Viral load blood test results are expressed as the number of copies (of HIV) per milliliter of blood plasma. less than 50 copies/ml) than those receiving placeboA dummy medical treatment, designed to have no pharmacological effect, administered to the control group of a clinical trial. plus background regimen, with comparable tolerability and no new safety signals reported since week 24.

http://journals.lww.com/aidsonline/Abstract/2009/11130/Efficacy(Of a drug or treatment). The maximum ability of a drug or treatment to produce a result regardless of dosage. A drug passes efficacy trials if it is effective at the dose tested and against the illness for which it is prescribed. In the standard procedure, Phase II clinical trials gauge efficacy, and Phase III trials confirm it._and_safety_of_etravirine_in.6.aspx

Disclaimer

While NAPWHA 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.

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This Clinical trial was first published on 10 May 2007 — more than six years ago.

While the content of this clinical trial was checked for accuracy at the time of publication, NAPWHA 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. NAPWHA 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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