International Network for Strategic Initiatives in Global HIV Trials (INSIGHT): START

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Investigator: Steven G. Deeks, MD
Sponsor: University of Minnesota

Location(s): South Africa; Mali; Brazil; Peru

Description

There is uncertainty concerning the optimal time to begin antiretroviral therapy (ART) for asymptomatic HIV-positive individuals with CD4+ cell count >500 cells/mm3. The Strategic Timing of Antiretroviral Treatment (START) is an international randomized trial designed to determine whether initiation of ART at CD4+ counts >500 cells/mm3 (immediate or early ART) is superior in terms of morbidity and mortality to deferral of ART until the CD4+ declines to 350 cells/mm3 (deferred ART). 

There is uncertainty concerning the optimal time to begin antiretroviral therapy (ART) for asymptomatic HIV-positive individuals with CD4+ cell count >500 cells/mm3. The Strategic Timing of Antiretroviral Treatment (START) is an international randomized trial designed to determine whether initiation of ART at CD4+ counts >500 cells/mm3 (immediate or early ART) is superior in terms of morbidity and mortality to deferral of ART until the CD4+ declines to 350 cells/mm3 (deferred ART). With this proposal, investigators in the International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) will complete follow-up of 4,685 HIV-positive participants already randomized in the START trial;databases will be finalized following study completion;biological specimens will be centrally stored;participants on ART will be transitioned to local sources from the central drug repository; and 10 papers will be prepared for submission to major medical journals. One of these papers will summarize the primary results of the trial and be submitted for publication immediately following study closure. Findings of START will also be presented at scientific conferences.