What is the most important information I should know about Remune?
- Remune is an immune-based therapy being developed by the Immune Response Corporation. It has not yet been evaluated by the U.S. Food and Drug Administration (FDA) for use by people living with HIV.
- The developer of Remune is now focusing on the development of IR103, an immune based therapy containing Remune and an adjuvant called Amplivax™..
- Neither Remune nore IR103 are being developed as an HIV immune-based therapy for HIV.
What is Remune?
- Remune is simply a form of HIV that has been altered and killed so that it won't cause damage to the immune system once inside the human body. All of HIV's genetic material is included in the drug. Aside from being a dead form of the virus, also missing is a key protein on HIV's shell – gp120 – which prevents the virus from actually infecting T-cells. This is how some HIV vaccines are being made. But, instead of using Remune to prevent people from becoming infected, it is being used to spark the immune response in people who are already infected with the virus.
What is already known about Remune?
- The standard dose used in clinical trials is 1 milliliter (mL), once every 3 months. It is administered using hypodermic needles and can be taken by patients at home.
- Remune doesn't attack HIV. The purpose of using Remune is to spark the activity of key cells in the immune system, particularly T-cells that can recognize HIV. If these "HIV-specific" T-cells are allowed to grow, they can signal other immune system cells to aid in the control of HIV. This might allow the immune system to gain better control of HIV – such as by halting the rate at which it damages the immune system – even in the absence of anti-HIV drugs.
- Like other drugs, Remune 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.
What has been learned in clinical trials?
- While studies have demonstrated that Remune can spark the production of HIV-specific T-cells, clinical trials did not show that Remune is of therapeutic benefit to people with HIV. The developer is now focusing on the development of IR103, which contains Remune and an adjuvant (Amplivax), an immune system stimulant being used to increase the body's immune response to Remune and HIV.
What is known about side effects?
- Remune appears to be very well tolerated and doesn't seem to be associated with any serious side effects.
- Other side effects may occur as a result of taking Remune. These have not yet been fully examined in clinical trials and have not yet been reviewed by the FDA.
Who should not take Remune?
- It is not known whether Remune 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 Remune 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 Remune?
- If you would like to find out if you are eligible for any clinical trials that include Remune, 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 email@example.com.