Volunteers are currently being recruited for a new medical study to help understand whether it is better to start taking HIV medicines as soon as people are diagnosed with HIV or whether to wait and follow the current guidelines based on CD4+ cell counts.
The Strategic Timing of Anti-Retroviral Treatment (START) study is an international study which is hoping to recruit 4000 people worldwide, including 20 people in Sheffield.
The study will aim to compare the risks and benefits of starting HIV medicines at CD4+ cell counts over 500/mm³ or waiting until CD4+ cell counts drop to 350/mm³ in people who are well.
Research has demonstrated that HIV medicines can prevent AIDS-related illnesses. These illnesses are rare when a CD4+ cell count is greater than 350/mm³. Recent research, however, suggests that HIV+ve people who aren’t taking HIV medicines may develop cancer or other illnesses affecting the heart, liver, or kidneys more than usual, even at higher CD4+ cell counts.
Participants in the START study will be divided into two groups: the EARLY Group and the DEFERRED group. If you are in the EARLY Group, you will take HIV medicines immediately and will continue taking HIV medicines to keep the amount of virus in your blood as low as possible. If you are in the DEFERRED Group and remain well, you will NOT take HIV medicines while in the study until your CD4+ cell count drops to 350/mm³. A computer will randomly decide which of the two groups you will join. Neither you nor your doctor can choose therefore you have to be comfortable in joining either group. There are possible benefits (pros) and risks (cons) of being in either group.
Who Can Join The Study?
You may be eligible to join the START study if you:
- Have been diagnosed HIV+ve
- Have never taken any HIV medicines,
- Have a CD4+ cell count of 500/mm3 or higher,
- Are aged 18 years or above
- Are in general good health with no recent history of major heart, liver, or kidney disease, and
- Are not pregnant or breastfeeding (for women).
If you are interested in joining the START study, please telephone Charlie Hughes (HIV Clinical Nurse Specialist and Research Nurse at the Royal Hallamshire Hospital, Sheffield) on 0114 271 3531 or talk to your health care provider and ask any questions you may have.
This international study, funded by the National Institutes of Health and other collaborating organizations, is being conducted by INSIGHT (International Network for Strategic Initiatives in Global HIV Trials) in conjunction with the Copenhagen HIV Programme (CHIP) in Denmark; the Medical Research Council (MRC) in the United Kingdom; the National Centre in HIV Epidemiology and Clinical Research (NCHECR) in Australia; the Washington International Coordinating Center in the United States; and the sponsor, the University of Minnesota.