IR103

What is the most important information I should know about IR103?

IR103 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.

What is IR103?

IR103 is a "therapeutic vaccine" – a vaccine designed to stimulate the immune system in people already infected with HIV.
IR103 is actually a combination of two drugs: the vaccine Remune® (HIV-1 immunogen) and the adjuvant Amplivax™ (HYP2055). Remune is a form of HIV that has been altered and killed so that it won't cause disease, but will stimulate an immune response to the virus. Amplivax is an adjuvant, an immune system stimulant used to increase the body's immune response to Remune and HIV.

What is already known about IR103?

IR103 is an injection. A dose has not yet been determined. In clinical trials, it is injected once every three months.
IR103 doesn't attack HIV. The theory behind the study of this drug is that the Remune in IR103 will trigger the production of cells responsible for controlling HIV infection – mature HIV-specific T-cells – and that the Amplivax in IR103 will further boost HIV-specific T-cell production and activity in the body. 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.
IR103 is the Immune Response Corporation's "second generation" immune-based treatment. Earlier studies using Remune alone, without Amplivax, indicated limited effectiveness.
Like other drugs, IR103 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?

In one Phase II study being conducted by the manufacturer, 31 patients who had not taken anti-HIV treatment – but had participated in an earlier study of Remune – received either IR103 or Remune every 12 weeks for a total of five injections. Data collected after 4 and 12 weeks in the study suggested that IR103 is more effective than Remune at producing mature HIV-specific T-cells. However, it still remains to be seen if this will help HIV-positive patients stay healthier and/or live longer, either while taking anti-HIV drug combinations or in the absence of anti-HIV drug therapy.
Another clinical trial is currently being conducted to evaluate safety and the ability of different IR103 doses to improve the HIV-specific activity of T-cells.

What is known about side effects?

No safety problems have been seen in the Phase II study of IR103 currently being conducted.
Side effects may occur as a result of taking IR103. These have not yet been fully examined in clinical trials and have not yet been reviewed by the FDA.

Who should not take IR103?

It is not known whether IR103 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 IR103 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.