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. Author manuscript; available in PMC: 2013 May 25.
Published in final edited form as: Clin Trials. 2012 Apr 30;10(1 0):S5–S36. doi: 10.1177/1740774512440342

Table 2.

START eligibility criteria

Inclusion criteria Exclusion criteria
Age >18 years Any previous use of ART or IL-2
Documentation of HIV-1 infection Diagnosis of any clinical AIDS event
Two CD4 cell counts >500 cells/μL at least 2 weeks apart within 60 days before randomization Presence of HIV disease progression such as oral thrush, unexplained weight loss, or unexplained fever
Karnofsky performance score ≥80. Perceived life expectancy of at least 6 months Cardiovascular event (myocardial infarction, angioplasty coronary artery bypass grafting, and stroke) within 6 months before randomization
For women of child-bearing potential, willingness to use contraceptives as described in the product information of the ART drugs they are prescribed Non-AIDS-defining cancer, excluding basal and squamous cell skin cancer, within 6 months before randomization. Dialysis within 6 months before randomization
History of decompensated liver disease
Current imprisonment, or compulsory detention (involuntary incarceration) for treatment of a psychiatric or physical illness

START: Strategic Timing of AntiRetroviral Treatment; ART: antiretroviral treatment; IL-2: interleukin-2; HIV-1: human immunodeficiency virus type 1; CD4: CD4+ T lymphocyte; AIDS: acquired immunodeficiency syndrome.