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What is the most important information I should know about T-1249?
- T-1249 was an experimental fusion inhibitor being developed by Trimeris and Hoffmann-La Roche. It has not been evaluated by the U.S. Food and Drug Administration (FDA) for use by people living with HIV.
- In January 2004, Trimeris and Hoffmann-La Roche announced that they would no longer be developing T-1249 for the treatment of HIV. Volunteers participating in clinical trials of T-1249 will continue to receive the drug. However, no additional clinical trials of T-1249 are planned.
What is T-1249?
- T-1249 is an anti-HIV medication. It is in a category of HIV medicines called fusion inhibitors, or more broadly, entry inhibitors.
- T-1249 binds to a protein on HIV's surface called gp41. Once it does this, HIV cannot successfully bind with the surface of T-cells, thus preventing the virus from infecting healthy cells.
- T-1249 will most likely need to be used in combination with other anti-HIV drugs.
What is already known about T-1249?
- A dose for T-1249 has not yet been determined. Because of its fragile structure (it is a peptide), T-1249 cannot be taken by mouth. It is currently being developed in an injectable form and will require once- or twice-daily shots.
- T-1249 may be active against HIV that is resistant to Fuzeon® (T-20), the first fusion inhibitor being developed by Trimeris and Roche.
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 T-1249 might interact with other medications, including those used to treat HIV. It is important that your personal physician and/or the research nurse or study investigator be aware of all drugs you are taking, including those you buy without a prescription.
- T-1249 holds promise for HIV-positive patients who have tried and failed other anti-HIV drugs in the past. Because T-1249 targets HIV differently than currently available drugs, chances are that most people living with the virus – regardless of their treatment history – will likely benefit from using T-1249.
What do we know about T-1249 from clinical trials?
- Early results from one clinical trial of T-1249 have been presented. This study enrolled 115 HIV-positive people, many of whom had tried and failed other anti-HIV drugs in the past. Before beginning T-1249 therapy, all of the volunteers stopped their anti-HIV treatments. Two weeks later, volunteers were given one of ten doses of T-1249, ranging from 6.25mg once a day to 200mg once a day. T-1249 treatment was continued, without any other anti-HIV drugs being used, for two weeks. After 14 days of treatment, viral load decreased by 2.0 log in some volunteers who received the highest dose of T-1249.
- In another clinical trial, 54 HIV-positive patients who became resistant to Fuzeon while participating in one of two phase III clinical trials of the drug were enrolled into another study of T-1249. In this study, Fuzeon therapy was stopped and T-1249 was taken for ten days, in combination with other anti-HIV drugs that were started at the beginning of the phase III Fuzeon studies. The T-1249 dose used was 192mg, administered by a shot once a day. All patients in this study had virus that was resistant to Fuzeon. After ten days of T-1249 treatment, 67% of patients saw their viral load decrease by more than 1 log. Patients who had been failing Fuzeon for less than one year were more likely to respond well to T-1249 treatment.
What is known about side effects?
- Skin irritation (e.g., itchiness and swelling) at the site where T-1249 is injected has been the most common side effect reported in studies thus far.
- Other side effects may occur as a result of taking T-1249. These have not yet been fully examined in clinical trials and have not yet been reviewed by the FDA.
Who should not take T-1249?
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 It is not known whether T-1249 will harm an unborn baby. It is very important to treat HIV/AIDS during pregnancy to reduce the risk of infecting your baby. Talk to your doctor about your treatment options.
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 It is not known whether T-1249 passes into breast milk and what effect it may have on a nursing baby. To prevent transmission of the virus to uninfected babies, it is recommended that HIV-positive mothers not breast-feed.
Where can I learn more about clinical trials of T-1249?
- You can call Trimeris at 919-419-6050 during normal business hours.
- If you would like to find out if you are eligible for any clinical trials that include T-1249, there is an interactive web site run by ACRIA, the AIDS Community Research Initiative of America.
- Another useful service for finding clinical trials is AIDSinfo.nih.gov, a site run by the U.S. National Institutes of Health. They have "health information specialists" you can talk to at their toll-free number at 1-800-HIV-0440 (1-800-448-0440).
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