What is the most important information I should know about BMS-561390?

• BMS-561390 is an experimental non-nucleoside reverse transcriptase inhibitor (NNRTI) being developed by Bristol-Myers Squibb. It has not yet been approved by the U.S. Food and Drug Administration (FDA) for use by people living with HIV. BMS-561390 is no longer being studied or developed for the treatment of HIV infection.

• BMS-561390 is an anti-HIV medication. It is in a category of HIV medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs). BMS-561390 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.
   
• BMS-561390 will need to be used in combination with other drugs. Clinical trials will evaluate its effect in combination with other drugs, including protease inhibitors (PIs) and nucleoside reverse transcriptase inhibitors (NRTIs).

• A dose for BMS-561390 has not yet been determined. BMS-561390 remains in the bloodstream for a long period of time – more than 90 hours after a single dose – which should allow the drug to be taken once a day. The dose currently being studied in clinical trials is 100 mg once a day.
   
• Like other NNRTIs, BMS-561390 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.
   
• Clinical trials of BMS-561390 are now under way. It is expected that BMS-561390, when combined with two nucleoside analogues, will have strong activity against HIV in people who have never taken an NNRTI in the past.
   
• It is not yet know if BMS-561390 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. HIV only needs to develop a single key mutation to become highly resistant to any of these drugs. Test tube studies have shown that BMS-561390 is still active against HIV containing single key mutations. However, it is not clear how effective the drug will be against HIV containing two or more of these key mutations. Clinical trials looking at the effect of BMS-561390 in people who have taken other NNRTIs in the past are currently being developed.

• The side effects of BMS-561390 have not yet been determined.

• It is not known whether BMS-561390 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.
   
• It is not known whether BMS-561390 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.

• If you would like to find out if you are eligible for any clinical trials that include BMS-561390, 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).