Community perspective on the INSIGHT S trategic T iming of AntiRetroviral T reatment ( START ) trial

Determining when to start antiretroviral treatment ( ART ) is vitally important for people living with HIV . Yet the optimal point at which to start to maximize clinical benefit remains unknown. In the absence of randomized studies, current guidelines rely on conflicting observational data and expert opinion, and consequently diverge on this point. In the USA , ART is recommended irrespective of CD 4 cell count. The W orld H ealth O rganization now recommends starting ART at a CD 4 cell count of 500 cells/μL, while the threshold for the UK and S outh A frica remains at 350 cells/μL. The S trategic T iming of AntiRetroviral T reatment ( START ) study, one of the largest clinical trials on the treatment of HIV infection, will answer this question. START compares two treatment strategies: immediate treatment at a CD 4 cell count of 500 cells/μL or higher versus deferring treatment until the CD 4 cell count decreases to 350 cells/μL or until AIDS develops. START includes seven substudies, five of which will clarify the relative contributions of HIV and ART in common comorbidities. START is fully enrolled and expected to be completed in 2016. HIV advocates support the study's design and have been involved from inception to enrolment. The trial will produce rigorous data on the benefits and risks of earlier treatment. It will inform policy and treatment advocacy globally, benefitting the health of HIV ‐positive people.