| 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 / 13 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 |