Potential patients will be asked to take part in the research study named above because they are infected with HIV, the virus that causes AIDS, and because they have a CD4 cell (also called T4 helper cells) count of at least 300 cells/mm3.
This is a study of an investigational drug called interleukin-2 (IL-2 or Aldesleukin). Before you can decide whether or not to take part in this study, we would like to explain the purpose of the study, how it may help you, any risks to you, and what is expected of you.
PURPOSE OF STUDY
IL-2 is produced naturally in the body and helps CD4 cells multiply. CD4 cells help fight infection. People with HIV infection have low levels of natural IL-2. Although IL-2 is not approved for treatment of HIV by the Therapeutic Goods Administration, it has been studied in human trials and most (but not all) participants who have received IL-2 in combination with anti-HIV drugs show increases in their CD4+ cell count. One study United Kingdom Vanguard Study showed that, over a six month period, most (but not all) of 24 participants who were given IL-2 without anti-HIV drugs had an increase in CD4 cell counts without increasing HIV viral load compared to 12 participants who received no therapy.
Although these results are encouraging, comparison with other studies suggests that giving IL-2 in combination with anti-HIV drugs may produce a greater increase in CD4+ cell count compared to administering IL-2 alone. We are conducting this study:
- to determine the safety and tolerance of IL-2 taken alone (without anti-HIV drugs);
- to determine the safety and tolerance of IL-2 when administered with anti-HIV drugs given during IL-2 cycles only;
- to see if the use of IL-2 alone or with anti-HIV drugs taken around IL-2 cycles causes an increase in CD4 cell count greater than no therapy at all;
- to see if the use of IL-2 alone or with anti-HIV drugs taken around IL-2 cycles causes changes in HIV viral load that are different compared to no therapy at all.
This study will enroll about 480 people around the world. The study will last about 2 years.
Information on the study provided herein is extracted from the consent form approved by the relevant Ethics Board– potential participants in the study should obtain the approved consent form for their review.
PLEASE SEE ALSO CLINICAL TRIALS OVERVIEW
For more information, or a copy of the Consent Form, please email us at trials@holdsworthhouse.com.au
Or call the trials team on (02) 9331 7228
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