START 2009.

Trial name or title	Strategic Timing of Antiretroviral Treatment (START)
Methods	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Participants	Patients 18 years of age and older who are infected with HIV, have CD4+ cell counts of greater than 500 cells/mm3, and who have never had antiretroviral therapy to treat HIV.
Interventions	To determine whether initiation of ART in HIV‐infected, treatment‐naive persons with CD4 counts > 500 cells/mm3 is superior in terms of mortality and morbidity to deferral of treatment until the CD4 count declines to < 350 cells/mm3.
Outcomes	Primary Outcomes: Composite endpoint of AIDS, serious non‐AIDS diagnoses, and all‐cause mortality Secondary Outcomes: Components of the composite primary outcome measure Specific non‐AIDS diagnoses Adverse events Hospitalization, health‐care utilization, quality of life HIV drug resistance and transmission risk behavior Change in neurocognitive function (in a subset of participants) Obtain a whole blood sample from which DNA will be extracted to study validated genetic variants that determine the risk of the various primary and secondary outcomes assessed in START (in a subset of participants) Evaluate understanding of study information and satisfaction with the consent process among START participants, after receiving information from either a standard or a concise consent form (at a subset of sites) Large and small artery elasticity (in a subset of participants)
Starting date	March 2009
Contact information	University of Minnesota (James D. Neaton, Ph.D/Principal Investigator)
Notes	NCT00867048