What is ibalizumab?

• Ibalizumab is an experimental entry inhibitor being developed by Taimed Biologics. It has not yet been evaluated by the U.S. Food and Drug Administration (FDA) for use by people living with HIV.
   
• Ibalizumab contains genetically engineered antibodies, known as monoclonal antibodies. These antibodies bind to the CD4 receptor on T-cells. Once ibalizumab binds to these receptors, HIV cannot successfully connect with the surface of T-cells, thus preventing the virus from infecting healthy cells.
   
• Ibalizumab will most likely need to be used in combination with other anti-HIV drugs.

• A dose for ibalizumab has not yet been determined. The drug is administered intravenously, once every two weeks, using a dose that depends on body weight.
   
• Ibalizumab holds promise for HIV-positive patients who no longer respond to other anti-HIV drugs. Because ibalizumab targets HIV differently than most currently available drugs, chances are that most people living with the virus—regardless of which drugs they have tried (and failed) in the past—will likely benefit from using ibalizumab.
   
• It is not known how quickly resistance to ibalizumab develops if resistance does occur.
   
• Ibalizumab 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.
   
• A Phase II study of ibalizumab will be enrolling in 2009 and scheduled to complete by 2010.

• No studies have yet reported whether ibalizumab may interact with other drugs. Trials to determine potential drug interactions are planned or ongoing.

• Information regarding the safety and possible side effects of ibalizumab in HIV-positive people has not yet ben reported. Studies to determine the potential side effects of ibalizumab are planned or ongoing.

• It is not known whether ibalizumab 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 ibalizumab 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 ibalizumab, 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).