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BLQ study (darunavir plus enfuvirtide)

Clinical trial • Reported • 11 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 study looked at the new protease inhibitor (PIA type of anti-HIV drug that works by preventing the production of an enzyme, protease, that HIV needs to replicate.) darunavir and how safe, effective and easy-to-take it is with an 'optimised background regimen' including enfuvirtide (T-20).

The trial enrolled people who had been on triple-class therapy before but had never had enfuvirtide or darunavir.

Official title:An Open-Label Study to Evaluate the Effect on Viral Load of a New Investigational Protease Inhibitor With Fuzeon Plus a Background Antiretroviral Regimen in Triple-Class Treatment-Experienced Patients With HIV-1 Infection
What is this trial studying?Existing drug – darunavir, enfuvirtide (T-20)
How many participants will this trial enrol?141

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 drugs for 24 weeks.
Links to further information:
Can I access this treatment other than by enrolling in this trial?

Darunavir and enfuvirtide are both available in Australia through the Pharmaceutical Benefits Scheme[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. (PBS)

Tags: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
  • Have taken HIV treatments in the past
You will not be eligible to participate in this trial if you meet any of the following criteria:
  • Taken enfuvirtide before

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:

The investigators concluded: "In this sample [Expanded AccessBefore a drug has been approved, manufacturers often provide the drug free of charge to people who cannot participate in a clinical trial and who meet certain criteria under a Special Access Scheme (SAS). Program] population of treatment-experienced patients, virologic responses at week 24 were uniformly excellent when darunavir/ritonavir and enfuvirtide were combined with optimized background therapy in patients naive to these 2 drugs."

See link above for full summary

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 11 May 2007 — more than four years 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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