ESP study (adding T-20)

This trial has been cancelled. Clinical trials may be cancelled prior to commencement, or during the course of the trial, for a number of reasons – these may be summarised below. You cannot enrol in this trial.

About this trial

This study was going to look at the benefits of adding T-20 to people's existing regimens, but recruitment was too slow so the study has been cancelled. Participants were to be randomized to receive T-20 in addition to their current antiretroviral therapy or to continue their current antiretroviral therapy alone.

Background information

T-20 (enfuviritide or Fuzeon) is an entry inhibitor. It has to be injected subcutaneously twice-a-day so it's not the most convenient antiretroviral on the market which might account for the difficulty in recruiting people for this trial.

Official title:	A Randomized, Open Label Study to Determine the Immunological Benefits of Adding Fuzeon to an Antiretroviral Regimen in HIV-Infected Fuzeon-naïve Patients With Sustained HIV Viral Suppression
What is this trial studying?	Existing drug
How many participants will this trial enrol?	40 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.
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 CD4 count below 250 cells/mm³ Viral load below 400 copies/ml 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:	Clinical.trials.gov
Related trials:	ESP study (T-20 injection methods)
Can I access this treatment other than by enrolling in this trial?	Enfuviritide is an approved antiretroviral drug available through the PBS.
Keywords:	enfuvirtide

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.

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