Table 1: Summary of six treatment-interruption trials

Study TI strategy Months of prior therapy Number of subjects Nadir CD4-cell count* Baseline CD4-cell count* Key findings

Natural History of TI

ACTG 5170 Therapy restarted at the discretion of the patient & physician 54 167 436 833 Safe in terms of HIV disease progression, but 5 deaths occurred, raising questions about the advisability of this TI strategy
Fixed-Interval TI

ISS PART 3 mos on / 1–3 mos off 26 CT = 137 TI = 136 420 740 CT and TI arms similar; 30% resistance in TI arm
ANRS 106 8 wks on / 8 wks off 63 CT = 194 TI = 197 280 741 CT and TI arms similar; no difference in resistance
CD4-Based TI

ANRS 1269 Therapy restarted at CD4 count <250 cells/mm3 7 CT = 110 TI = 216 273 459 TI arm stopped because of increased risk for morbidity (RR, 2.3)
SMART Therapy restarted at CD4 count <250 cells/mm3 72 CT = 2752 TI = 2720 253 598 TI arm stopped because of increased risk for disease progression or death (RR, 2.2)
STACCATO Therapy restarted at CD4 count <350 cells/mm3 15 CT = 146 TI = 284 260 490 No difference in proportion suppressed

TI=treatment interruption, CT=continuous therapy, RR=relative risk, * in cells/mm3