title: Demographic and HIV-specific characteristics of participants enrolled in the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial.
abstract: OBJECTIVE
  The risks and benefits of initiating antiretroviral treatment (ART) at high CD4 cell counts have not been reliably quantified. The Strategic Timing of AntiRetroviral Treatment (START) study is a randomized international clinical trial that compares immediate with deferred initiation of ART for HIV-positive individuals with CD4 cell counts above 500 cells/μL. We describe the demographics, HIV-specific characteristics and medical history of this cohort.
  
  
  METHODS
  Data collected at baseline include demographics, HIV-specific laboratory values, prior medical diagnoses and concomitant medications. Baseline characteristics were compared by geographical region, gender and age.
  
  
  RESULTS
  START enrolled 4685 HIV-positive participants from 215 sites in 35 countries. The median age is 36 years [interquartile range (IQR) 29-44 years], 27% are female, and 45% self-identify as white, 30% as black, 14% as Latino/Hispanic, 8% as Asian and 3% as other. The route of HIV acquisition is reported as men who have sex with men in 55% of participants, heterosexual sex in 38%, injecting drug use in 1% and other/unknown in 5%. Median time since HIV diagnosis is 1.0 year (IQR 0.4-3.0 years) and the median CD4 cell count and HIV RNA values at study entry are 651 cells/μL (IQR 584-765 cells/μL) and 12,754 HIV RNA copies/mL (IQR 3014-43,607 copies/mL), respectively.
  
  
  CONCLUSIONS
  START has enrolled a diverse group of ART-naïve individuals with high CD4 cell counts who are comparable to the HIV-positive population from the regions in which they were enrolled. The information collected with this robust study design will provide a database with which to evaluate the risks and benefits of early ART use for many important outcomes.
authors.affiliation: Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN, USA.
authors.forename: S
authors.initials: S
authors.lastname: Sharma
authors.forename: A G
authors.initials: AG
authors.lastname: Babiker
authors.forename: S
authors.initials: S
authors.lastname: Emery
authors.forename: F M
authors.initials: FM
authors.lastname: Gordin
authors.forename: J D
authors.initials: JD
authors.lastname: Lundgren
authors.forename: J N
authors.initials: JN
authors.lastname: Neaton
authors.forename: E
authors.initials: E
authors.lastname: Bakowska
authors.forename: M
authors.initials: M
authors.lastname: Schechter
authors.forename: M J
authors.initials: MJ
authors.lastname: Wiselka
authors.forename: M J
authors.initials: MJ
authors.lastname: Wolff
mesh_terms: D000328:Adult; D044966:Anti-Retroviral Agents / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active / Q000379:methods*; D018791:CD4 Lymphocyte Count; D015331:Cohort Studies; D003710:Demography; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000473:pathology; D006801:Humans; D008297:Male; D008875:Middle Aged; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D044966:Anti-Retroviral Agents
keywords: HIV; START trial; clinical trial; when to start antiretroviral therapy