J D Lundgren

Dr J D Lundgren, University of Copenhagen, Copenhagen, Denmark; jdl@cphiv.dk

STUDY DESIGN

Design:

randomised controlled trial (RCT) (Strategies for Management of AntiRetroviral Therapy [SMART] study). ClinicalTrials.gov NCT00027352.

Allocation:

{concealed}*.†

Blinding:

{unblinded}‡.†

STUDY QUESTION

Setting:

318 clinical centres in 33 countries.

Patients:

5472 patients {>13 years of age (median age 43 y, 73% men)}‡ who had HIV and CD4⁺ cell counts >350 cells/µl.

Intervention:

drug conservation (DC), with CD4⁺ cell count–guided antiretroviral therapy (ART) interruption (ART stopped at counts >350 cells/µl and restarted at counts <250 cells/µl) (n = 2720), or viral suppression (VS) with continuous ART (n = 2752).

Outcomes:

composite of opportunistic disease (OD) or death. Other outcomes included fatal or non-fatal OD, and non-OD death.

Follow-up period:

2 and 4 months, then every 4 months (mean follow-up 16 …