TMC278 (rilpivirine) versus efavirenz (2 trials)

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

These two trials are for people who have never taken any anti-HIV drugs in the past.

They are both comparing the effectiveness(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., safety and tolerability of rilpivirine (TMC278) - a new Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI)- against efavirenz - another NNRTI.

One trial stipulates the use of tenofovir/emtricitabine(FTC) as the background regimen.

The other trial gives you the choice of background regimen from these combinations: abacavir/lamivudine(3TC), tenofovir/emtricitabine(FTC) or zidovudine(AZT)/lamivudine(3TC).

Background information

NNRTIs (or non-nukes) form the backbone of many people's treatment regimens. Currently there are only three approved drugs available in this class and people often develop resistance to one or all of them.

Official title:

A Phase III, Randomized, Double-Blind Trial of TMC278 25mg q.d. Versus Efavirenz 600mg q.d. in Combination With a Background Regimen Containing 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in Antiretroviral-Naive HIV-1 Infected Subjects >>>>> AND <<<< A Phase III, Randomized, Double-Blind Trial of TMC278 25 mg q.d. Versus Efavirenz 600mg q.d. in Combination With a Fixed Background Regimen Consisting of Tenofovir Disoproxil Fumarate and Emtricitabine in Antiretroviral-Naive HIV-1 Infected Subjects.

What is this trial studying?

new_drug – rilpivirine (TMC 278)

Start date:

May 2008 (This may be the proposed or expected start date for trials which have not yet started.)

How many participants will this trial enrol?

1360 (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 96 weeks.

Links to further information:

• http://www.hivandhepatitis.com/2007icr/croi/docs/030207_dd.html
• http://clinicaltrials.gov/ct2/show/NCT00543725?term=HIV+AND+Australia&rank=31&show_locs=Y#locn
• http://clinicaltrials.gov/ct2/show/NCT00540449?term=TMC278-TiDP6-C209&rank=1&show_locs=Y#locn

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 never taken HIV treatments
• Viral load at least 5000 copies/ml

You will not be eligible to participate in this trial if you meet any of the following criteria:

• You must not have multiple HIV drug resistance

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, visit the NAPWA website for background information on participating in clinical research.

Contact NAPWA if you have any questions or comments about this trial.