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.