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

TY - JOUR

T1 - Demographic and HIV-specific characteristics of participants enrolled in the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial

AU - Sharma, S

AU - Babiker, A G

AU - Emery, S

AU - Gordin, F M

AU - Lundgren, J D

AU - Neaton, J N

AU - Bakowska, E

AU - Schechter, M

AU - Wiselka, M J

AU - Wolff, M J

AU - International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group

N1 - © 2015 British HIV Association.

PY - 2015/4/1

Y1 - 2015/4/1

N2 - 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.

AB - 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.

KW - Adult

KW - Anti-Retroviral Agents

KW - Antiretroviral Therapy, Highly Active

KW - CD4 Lymphocyte Count

KW - Cohort Studies

KW - Demography

KW - Female

KW - HIV Infections

KW - Humans

KW - Male

KW - Middle Aged

KW - Time Factors

KW - Treatment Outcome

U2 - 10.1111/hiv.12231

DO - 10.1111/hiv.12231

M3 - Journal article

C2 - 25711321

SN - 1464-2662

VL - 16

SP - 30

EP - 36

JO - HIV Medicine

JF - HIV Medicine

IS - Suppl 1

ER -