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What is the most important information I should know about TMC-120?
- TMC-120 is an experimental non-nucleoside reverse transcriptase inhibitor (NNRTI) being developed by Tibotec, a biotechnology company in Belgium. It has not yet been evaluated by the U.S. Food and Drug Administration (FDA) for use by people living with HIV.
- The development of TMC-120 was halted by Tibotec in 2003, and they decided to concentrate their efforts on TMC-125, another NNRTI that can be more easily absorbed in the body. In March 2004, Tibotec signed a royalty-free agreement with the International Partnership for Microbicides, a non-profit organization that will study TMC-120 as a preventive gel that might block HIV infection during sexual intercourse.
What is TMC-120?
- TMC-120 is in a category of HIV medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs). TMC-120 prevents HIV from entering the nucleus of healthy T-cells. This prevents the cells from producing new virus and decreases the amount of virus in the body.
- TMC-120 will need to be used in combination with other drugs. Clinical trials will evaluate its effect in combination with other drugs, including protease inhibitors and nucleoside reverse transcriptase inhibitors.
What is already known about TMC-120?
- The correct dose for TMC-120 has not yet been determined. In one clinical trial that has been reported, the dose used was 100mg twice a day.
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 Like other NNRTIs, TMC-120 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.
- It is expected that TMC-120, when combined with two nucleoside reverse transcriptase inhibitors, will have strong activity against HIV in people who have never taken an NNRTI in the past. In one clinical trial, HIV-positive people who had not taken any other drugs in the past saw their viral load decrease by approximately 1.5 log and their T-cell count increase by approximately 120 after taking either 50 mg or 100mg of TMC-120 twice daily (without other anti-HIV drugs) for one week. More information from this study and other clinical trials is expected soon.
- It is not yet known if TMC-120 will work against strains of HIV that are already resistant to currently available NNRTIs. All of the currently marketed NNRTIs are highly cross-resistant to each other. Test tube data suggest that TMC-120 might be effective against strains of HIV that are at least partly resistant to any of the approved drugs. But this cannot be determined until information from clinical trials is made available.
What is known about side effects?
- The side effects of TMC-120 have not yet been determined. However, in one study involving 43 HIV-positive people who took TMC-120 for seven days, the drug was said to be "well tolerated."
Who should not take TMC-120?
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 It is not known whether TMC-120 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 TMC-120 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 TMC-120?
- If you would like to find out if you are eligible for any clinical trials that include TMC-120, 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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