START
Initiation of Antiretroviral Therapy in Early Asymptomatic HIV Infection
Patient / Population Intervention / Exposure Comparison Outcome
In 4,684 ART-naïve adults with CD4 >500/µL, immediate antiretroviral therapy reduced serious AIDS and non-AIDS events compared with deferred ART.
N
4,685
Design
Open-label RCT
Endpoint
Composite of serious AIDS / non-AIDS events or death
Relevance
1
ResultHR 0.43; 57 % relative reduction in the immediate-ART arm.
INSIGHT START Study Group. N Engl J Med. 2015;373(9):795-807. 10.1056/NEJMoa1506816
Discussion & critique
Established universal treat-at-any-CD4 — combined with TEMPRANO, drove the 2015 WHO and US guidelines.