People with HIV in the UK are being offered a final opportunity to enroll in a major international trial into a naturally occurring substance in the body which may be able ot boost the immne system's response to HIV.
The study, called ESPRIT (Evaluation of Subcutaneous Proluekin in a Randomised International Study), is assessing the use of interlukin-2 (IL-2), which is produced naturally by the body and helps key immune system CD4 T-cells to multiply. It is already known that IL-2 can increase CD4 production in people with HIV, but it is not known if this decreases the risk of becoming ill because of HIV. The study is designed to find this out.
It is hoped to recruit 300 people to the study in the UK, and 4000 people internationally. So far 287 people have volunteered to take part in the study in this country and a final recruitment push is underway to fill the remaining places. Recruitment to the study is taking place at 24 specialist HIV clinics around the UK, and these clinics are being offered additional places to help meet the international recruitment target.
ESPRIT is open to people with HIV, aged 18 or above who are well, on HAART with a CD4 count above 300 cells/mm3. People enrolling onto the trial are allocated at random to one of two treatment arms. As well as remaining on their existing HAART regimen, people in the first treatment arm will receive a dose of IL-2 every 12 hours for five days once every eight weeks. The second arm of the study is being recruited for control purposes and will only receive their HAART combination. At the end of the study, researchers will compare lab results and the frequency of ill health and side effects between the two groups to see if there are benefits to taking IL-2 with combination therapy.
Side-effects for IL-2 are most likely to occur during the five day injection period and include a flu-like illness, diarrhoea, nausea, headaches, sleeplessness and fatigue. Because of the side-effects, some people are unable to work during the five days of IL-2 treatment.
To find out more about the ESPRIT trial click here. The pro’s and con’s of participating in a clinical trial are discussed here and in the Clinical Trials booklet in the NAM information for HIV-positive people series.
The study website can be found at http://www.esprit.org.