About this trial
This study looked at the new protease inhibitor (PI) 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 |
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| What is this trial studying? | Existing drug |
| 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 drug for 24 weeks. |
| Who can enrol in this trial? | You may be eligible to participate in this trial if you meet the following criteria:
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| Links to further information: | |
| Results: | The investigators concluded: "In this sample [Expanded Access 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 |
| 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 (PBS) |
| Keywords: | darunavir, enfuvirtide, optimised background regimens, protease inhibitors |
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
- Call the Treataware info line if you need further advice
If you've ever participated in a clinical trial, or tried to make sense of scientific research reports, you may have found some of the specialised language confusing to say the least. This Backgrounder (from the Nov-Dec 2002 edition of Positive Living) looks at the vocabulary of clinical trials.