Table 2.
Main characteristics of trials considering ART treatment-experienced adult patients.
| Trial | Reference(s) | Enrollment period | Geographic area | No. of enrolled subjects (treated:control) | Reason for discontinuation of earlier treatments | Patient characteristics at baseline: - Median/mean age - Median/mean time since treatment started - Cutoff for plasma viral load (copies/ml) - Cutoff for CD4 cell count |
Duration of follow-up (weeks) | DRV group regimen | Control group regimen |
|---|---|---|---|---|---|---|---|---|---|
| Treatment-experienced failing subjects, DRV 600 mg BID (3 studies; 1440 total patients enrolled) | |||||||||
| ODIN | Cahn P8 | NA | North, Central and South America, Europe, Australia and Asia | 590 (294:296) |
Treatment simplification | -40.2 y (mean age) in the study group and 40.7 y (mean) in the control group - pVL > 1000 - CD4 < 50 |
48 | DRV/r (600 mg BID) | DRV/r (800 mg OD) |
| POWER (1–2) |
Clotet B22 | 2005 | Multicentric | 255 (131:124) |
Increase in drug resistance | -43.9 y (mean age) in the study group and 44.4 y (mean) in the control group - pVL > 1000 - at least one primary PI mutation |
48 | DRV/r (4 dosages; only 600 mg BID was included in the meta-analysis) | Control PI |
| TITAN | Madruga JV9 | 2005–2007 | Multicentric | 595 (298:297) |
DRV experienced in the border range | - 40 y (mean age) - 9.1 y (mean duration of infection) - pVL > 1000 - CD4 not limited |
48 | DRV/r (600 mg BID) + OBR | LPV/r + OBR |
| Banhegyi D11 | 96 | ||||||||
| Treatment-experienced, virologically controlled subjects, DRV 800 mg/d (11 studies; 1046 total patients enrolled) | |||||||||
| 2PM STUDY | Gianotti N49 | 2013–2014 | Italy | 43 (15:13:15) |
NA | -Adult - 46 y (median age) - pVL < 50 - CD4 > 200 |
48 | DRV/r (800 mg) |
1) LPV/r 2) Triple |
| DRIVESHAFT | Huhn GD50 | NA | NA | 60 (30:30) |
NA | - median age and previous ART duration are NA - pVL < 40 - CD4 not limited |
48 | DRV/r (800 mg OD) |
DRV/r (600 mg BID) |
| DRV600 | Moltó J51 | 2012–2013 | Spain | 100 (50:50) |
NA | - 45.2 y (mean age) - 8.5 y (mean time since diagnosis) - pVL < 50 - CD4 not limited |
48 | DRV/r (800 mg) |
DRV/r (600 mg) |
| LOPIDAR | Santos J R52 | NA | Spain | 75 (40:33) |
Treatment simplification | - 43 y (median age) - 108 w (median HIV diagnosis) - pVL < 50 CD4nadir > 100 |
48 | DRV/r (800 mg) | LPV/r |
| MIDAS | Hamzah L53 | NA | NA | 64 (32:32) |
Side effects | -age NA - pVL < 50 - CD4 not limited |
48 | DRV/r (800 mg) | TDF/FTC/EFV |
| MONARCH | Guaraldi G54 | NA | Italy | 30 (15:15) |
NA | - 45 y (median age) in the study group and 43 y (median) in the control group -pVL < 50 - CD4 > 200 - CD4nadir > 100 |
48 48 |
DRV/r (800 mg) + NRTIs (triple) |
DRV/r (800 mg) monotherapy |
| MONET | Arribas JR28 | 2007–2008 | Europe | 256 (127:129) |
NA | - 44 y (median age) - 7.4 y (mean) in art in the study group and 5.9 y in the control group - pVL < 50 - CD4 > 200 |
48 | DRV/r (800 mg) + NRTIs | DRV/r (800 mg) monotherapy |
| Clumeck N55 | 96 | ||||||||
| PROBE | Maggiolo F56 | 2014 | Italy | 60 (30:30) |
Avoid drawbacks and toxicities due to the nucleoside backbone | - 49 y (median) in the DRV group and 48 y in the control group - 93 m (median previous art) in the DRV group and 98 m in the control group - pVL < 50 - CD4 not limited - negative HBV |
48 | DRV/r (800 mg) + RPV | Triple |
| PROTEA | Antinori A29 | NA | Europe and Israel | 273 (137:136) |
NA | - 42 y (mean age) -pVL < 50 for the previous 48 w - CD4 > 200 |
48 | DRV/r (800 mg) + 2NRTIs (triple) |
DRV/r (800 mg) monotherapy |
| Girard PM57 | 96 | ||||||||
| SPARE | Nishijima T58 | 2011 | Japan | 58 (28:30) |
NA | - 44 y (median age) in the study group and 39 y in the control group - pVL < 50 CD4 not limited |
48 | DRV/r (800 mg) + RAL | LPV/r + TVD |
| Treatment-experienced subjects, mixed/other combinations (1 study; 225 total patients enrolled) | |||||||||
| MONOI | Katlama C30 | 2007–2008 | France | 225 (112:113) |
NA | - 46 y (median age) in the study group and 45 y in the control group -pVL < 50 -pVL < 400 for > 18 m |
48 | DRV/r (600 mg BID, switched to 800 mg OD if pVL < 50 at w48) + NRTIs (triple) |
DRV/r (600 mg BID, switched to 800 mg OD if pVL < 50 at w48) monotherapy |
| Valantin MA21 | 96 | ||||||||
NA: Not applicable