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GSK-2248761
Pronunciation(s):
What is the most important information I should know about GSK-2248761?
- GSK-2248761 is an experimental non-nucleoside reverse transcriptase inhibitor (NNRTI) being developed by ViiV Healthcare. It has not yet been evaluated by the U.S. Food and Drug Administration (FDA) for use by people living with HIV.
It was originally developed by Idenix Pharmaceuticals and was formerly identified as IDX-12899.
- In February 2011, ViiV Healthcare announced that the U.S Food and Drug Administration (FDA) has placed a hold on the development of GSK-2248761. It is unclear if or when development will continue.
What is GSK-2248761?
- GSK-2248761 is in a category of HIV medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs). GSK-2248761 prevents HIV from entering the nucleus of healthy CD4 cells. This prevents the cells from producing new virus and decreases the amount of virus in the body.
- GSK-2248761 will need to be used in combination with other drugs. Clinical trials will evaluate its effect in combination with other drugs, including nucleoside reverse transcriptase inhibitors (NRTIs).
What is already known about GSK-2248761?
- The correct dose for GSK-2248761 has not yet been determined. Preliminary experiments suggest that the drug can be taken by mouth once a day.
 Like other NNRTIs, GSK-2248761 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 GSK-2248761, when combined with other HIV medications, will have strong activity against HIV in people who have never taken an NNRTI in the past. A Phase I study, testing 200mg, 400mg and 800mg doses of the drug as monotherapy (not in combination with other HIV medications) found that GSK-2248761 has potent antiviral activity after a seven-day course of treatment. A phase II study is now being conducted.
- It is not yet known if GSK-2248761 will work against strains of HIV that are already resistant to currently available NNRTIs.
What about drug interactions?
- There have not yet been studies demonstrating which other drugs may interact with GSK-2248761. Studies to help determine this are planned or ongoing.
What is known about side effects?
- Little is known about GSK-2248761's side effect profile. It was well tolerated in the seven-day Phase I study reported to date.
Who should not take GSK-2248761?
 It is not known whether GSK-2248761 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 GSK-2248761 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 GSK-2248761?
- If you would like to find out if you are eligible for any clinical trials that include GSK-2248761, 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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