Before we get started, I am going to start out with a list of words and their meaning to help you understand the mechanics of IL-2 and the study.
|Interleukins: a group of proteins that signal white blood cells to initiate an immune response to foreign substances, including cancer.
Interleukin-2 (IL-2): a protein made by the body. T-helper cells, a kind of white blood cell, produce IL-2 when they are stimulated by an infection.
Proleukin: manufactured IL-2 created through gene splicing and developed by Chiron Corporation.
Randomized: the process of assigning people to study groups by chance, much like flipping a coin. When people are assigned to groups this way any differences between groups at the end of the trial are more likely to be due to the treatment, not the characteristics of the people selected.
SILCAAT: a randomized study to compare the clinical results of people living with advanced HIV infection who are treated with IL-2 plus stable anti-retroviral therapies (ART) to a control group of individuals treated with stable ART alone. This pivotal study's primary objective is to determine if intermittent cycles of IL-2 delay the occurrence of opportunistic infections and the progression of advanced HIV disease compared to ART alone. This study is designed for people who have T-cells between 50 and 300 cells/mm3 and a viral load of less than 10,000 copies/mL. This study is expected to last for four to six years.
ESPRIT: a randomized, international, five-year, 40,000 person study of Interleukin-2 in people with HIV infection and a CD4+ cell count of at least 300/mm3. The purpose of this study is to find out whether IL-2, taken along with anti-HIV drugs, can keep people from getting sick and help them live longer.
Dr. Thompson began by giving an overview of what IL-2 can do, where it came from, and a list of side effects that patients may experience.
Originally manufactured to treat metastatic renal cell cancer and melanoma, IL-2 is currently being evaluated in two different types of clinical trials related to HIV, SILCAAT and ESPRIT. In both of these trials, the benefit of IL-2 in persons with HIV is being examined due to the ability IL-2 has in boosting the immune system. Although very toxic, early data has shown evidence of an increase in the number of T-cells when IL-2 is given in combination with antiretrovirals.
SILCAAT, the study offered by ARCA, is currently enrolling for people who meet the following requirements:
NOTE: This is not a complete list; there are other requirements for the study.
The study does not have a cost and you will be provided with the drug(s) in your treatment group but not with any other medications. All tests and procedures for the study will be provided at no cost to you. Those who are assigned to get IL-2 will administer five-day cycles of two subcutaneous (below the skin) injections a day.
ESPRIT, the study offered by a number of clinic sites throughout the country has the following requirements:
Those who are assigned to get IL-2 will have five days of twice-daily injections under the skin every eight weeks.
Those who are interested in IL-2, you must be aware of the side effects that can occur with this treatment. They include the following:
Tips for managing IL-2 side effects were described in detail by the patient who has completed four cycles of IL-2. He recommends that folks drink lots of water and Gatorade as well as take Tylenol every four hours two days prior to the treatment. He also suggests you keep a heavy coat of vaseline on your feet and hands to help prevent dryness as well as a supply of anti-nausea medicine in your cabinet in case you feel nausea. He also suggests approximately three days before IL-2 you change to a bland diet which would include Gatorade and Jell-O in order to lessen the severity of diarrhea. Most importantly, keep a diary about everything that happens during your five-day regimen. This information will help your study team and your caregivers.
As patients consider this study as an option in treatment, they must compare and balance potential benefits as well as drawbacks. For the medical community still has not come to a conclusion on the value of the new T-cells generated by IL-2. It can not bring T-cells "back from the dead" and you are only able to "manufacture" more of the T-cells that still exist. (Example: Let's say the "letters" (types of T-cells) that you need to fight off pneumonia are Z, E, B, R, and A and you have lost all of your copies of letter Z, you can not spell zebra and you might develop pneumonia.)
The question remains: is "manufacturing" more of the existing T-cells enough to keep the HIV community well and opportunistic free? We will never know unless you sign up with ARCA or a study site in your area and help find the answer.
(Information also gathered from New Mexico AIDS InfoNet, Project Inform, Chiron Corporation, and The Hopkins HIV Report.)
www.espritstudy.org (lists study sites)
Atlanta VA Medical Center (ESPRIT)
1670 Clairmont Road
Decatur, GA. 30033