Strategic Timing of AntiRetroviral Treatment (START)
Research type
Research Study
Full title
Strategic Timing of AntiRetroviral Treatment (START)
IRAS ID
7979
Sponsor organisation
Regents of the University of Minnesota, USA
Eudract number
2008-006439-12
Clinicaltrials.gov Identifier
Research summary
HIV medicines prevent AIDS-related illnesses. These illnesses are rare when the immune system is relatively strong (as measured by a CD4 count above 350 cells). Therefore, most guidelines recommend that HIV-infected People'should only start medicine when their CD4 count falls below 350 cells. Recent research suggests that people with HIV may be at increased risk of developing serious illnesses other than AIDS. These other illnesses (non-AIDS illnesses) include heart, liver, and kidney disease and cancers that occur at higher CD4 cell counts.The START study will evaluate if starting HIV medicines earlier - before CD4 cells drop to below 500 cells/mmü - will reduce the risk of developing serious non-AIDS illnesses as well as reduce the risk of the traditional AIDS illnesses.Eligible participants will have never had HIV medicines (antiretroviral therapy, ART) before, and will have a CD4 count greater 500 cells/mm3. Participants will be assigned to either the EARLY or DEFERRED treatment group:* EARLY Group will start treatment immediately (i.e. with a CD4 cell count above 500)* DEFERRED Group (provided they remain well) will wait until their CD4 cells drop to below 350 before starting treatment (this group is treated following current guidelines). Treatment will be with standard licensed ART drugs. Patients will be seen every 4 months during the study for routine blood tests and clinical evaluation. The rate of development of AIDS and serious non-AIDS events will be compared between the two groups.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
09/H1306/64
Date of REC Opinion
29 Jul 2009
REC opinion
Further Information Favourable Opinion