Immunitin (HE2000; alpha-epibromide)

• Immunitin is an experimental anti-HIV drug being developed by HollisEden Pharmaceuticals. It is currently in Phase II clinical trials.

What is Immunitin?

• Immunitin is an anti-HIV medication. It is in a new category of HIV medicines known as immune regulating hormones, and is a formulation of a compound called alpha-epibromide.
   
• Immunitin is similar to the hormone DHEA, which helps maintain testosterone levels in men and estrogen levels in women. It works differently than any of the anti-HIV drugs that are currently available.
   
• It is not clear how Immunitin works. This hormonal drug appears to stimulate key parts of the immune system. It has been shown to boost key immune system cells (dendritic cells, killer cells, and Th1 cells). These cells play a large role in what is called “cell-mediated immunity.” This type of immune system activity helps in preventing opportunistic infections and maintaining better control over HIV.
   
• Immunitin also appears to be active against infections like malaria, cytomegalovirus (CMV), polio, and influenza.
   
• Immunitin will likely be used in combination with other anti-HIV drugs.

What is already known about Immunitin?

• At the present time, Immunitin must be injected under the skin every day for five days. Treatment is then stopped for six weeks. After six weeks, the Immunitin injections are repeated for another five days, and so on. The daily doses being studied in clinical trials are 50 mg and 100mg. The manufacturer is currently developing an oral formulation of Immunitin.
   
•  Like other drugs, Immunitin 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.
   
• Immunitin worked very well in monkeys infected with a virus similar to HIV. Monkeys infected with the virus who received injections of Immunitin ended up living at least twice as long as untreated monkeys infected with the same virus.
   
• One clinical trial involving 24 HIV-positive people in South Africa found that Immunitin had a long-lasting effect on viral load (viral load was approximately 75% lower in the study volunteers, three months after the treatment was stopped) and helped to boost key immune system cells believed to be associated with better health. However, there was no significant effect on total T-cell counts.
   
• Because Immunitin targets the immune system, not the virus, it is possible that drug resistance will be less of a problem than with currently approved anti-HIV medications. However, much more needs to be learned about this drug, including its activity against HIV resistant to currently available medications.

What is known about side effects?

• There is not a lot of information about the potential side effects of Immunitin. However, it appeared to be well tolerated by patients who took the drug in an early clinical trial. The most common side effect was soreness at the site of injection.
   
• Other side effects may occur as a result of taking Immunitin. These have not yet been fully examined in clinical trials and have not yet been reviewed by the FDA.

Who should not take Immunitin?

•  It is not known whether Immunitin 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 Immunitin 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 Immunitin?

• If you would like to find out if you are eligible for any clinical trials that include Immunitin, 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).