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Demographic and HIV-specific characteristics of participants enrolled in the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial

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  • S Sharma
  • A G Babiker
  • S Emery
  • F M Gordin
  • J D Lundgren
  • J N Neaton
  • E Bakowska
  • M Schechter
  • M J Wiselka
  • Mathias Wolff
  • International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group
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OBJECTIVES: 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.

Original languageEnglish
JournalHIV Medicine
Volume16 Suppl 1
Pages (from-to)30-6
Number of pages7
Publication statusPublished - Apr 2015

    Research areas

  • Adult, Anti-Retroviral Agents, Antiretroviral Therapy, Highly Active, CD4 Lymphocyte Count, Cohort Studies, Demography, Female, HIV Infections, Humans, Male, Middle Aged, Time Factors, Treatment Outcome

ID: 45839660