Demographic and HIV-specific characteristics of participants enrolled in the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial
Wolff Reyes, Marcelo
Cita de ítem
HIV Medicine (2015), 16 (Suppl. 1), 30–36
Artículo de publicación ISI
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.
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.
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
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.