|What is SPI-452?
- SPI-452 is an experimental pharmacokinetic enhancer (a drug used to boost other medications in the blood to make them more effective) being developed by Sequoia Pharmaceuticals.
- The exact mechanism by which SPI-452 boosts the blood levels of other drugs has not yet been revealed, though it is likely that the drug inhibits a liver enzyme called CYP3A4.
- SPI-452 will need to be used in combination with other drugs. Clinical trials will evaluate its effect in combination with other drugs, including those currently approved for the treatment of HIV.
What is already known about SPI-452?
- The dose of SPI-452 has not yet been determined.
- It is likely that SPI-452 will 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.
- SPI-452 is currently being studied in combination with other HIV medications, notably protease inhibitors, to learn more about its safety and effectiveness. Future studies will likely compare SPI-452 to low-dose Norvir (ritonavir), the only agent currently approved to boost the levels of other HIV medications.
What about drug interactions?
- Studies on potential interactions between SPI-452 and other drugs have not yet been reported, but are planned and ongoing.
What is known about side effects?
- Studies evaluating the short- and long-term safety of SPI-452 are planned and ongoing.
Who should not take SPI-452?
- It is not known whether SPI-452 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 SPI-452 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 SPI-452?
- If you would like to find out if you are eligible for any clinical trials that include SPI-452, visit ClinicalTrials.gov, a site run by the U.S. National Institutes of Health. The site has information about all HIV-related clinical studies in the United States. For more info, you can call their toll-free number at 1-800-HIV-0440 (1-800-448-0440) or email firstname.lastname@example.org.