Table 1.
Trial | Reference(s) | Enrollment period | Geographic area | No. of enrolled subjects (treated:control) | Patient characteristics at baseline: -Median/mean age - Cutoff for plasma viral load (copies/ml) - Cutoff for CD4 cell count |
Duration of follow-up (weeks) | DRV group regimen | Control group regimen |
---|---|---|---|---|---|---|---|---|
ART - naïve patients (8 studies ; 4568 total patients enrolled) | ||||||||
ACTG 5257 | Lennox JL37, Ofotokun I43 |
2009–2011 | US & Puerto Rico | 1809 (601:605:603) | -37 y (median) - pVL > 1000 -CD4 not limited | 96 | DRV/r (800 mg/d) |
Two groups: 1) ATV/r 2) RAL |
ARTEMIS | Ortiz R4 | 2005–2008 | US, UK, Thailand, Argentina, France, Australia | 689 (343:346) |
-36 y (mean) in DRV/r and 35 (mean) in LPV/r -pVL ≥ 5000 -CD4 not limited |
48 | DRV/r (800 mg/d) |
LPV/r |
Mills AM5 | 96 | |||||||
Lathouwers E12 | 96 | |||||||
Orkin C10 | 192 | |||||||
ATADAR | Martinez E44 | 2011 | Spain | 178 (88:90) | -35 y (mean) treat vs 37 y (mean) control - pVL ≥ 1000 -CD4 not limited |
96 | DRV/r (800 mg/d) |
ATV/r |
FLAMINGO | Clotet B20 | 2011–2012 | Europe, US and South America | 484 (242:242) |
-Adult -34 y (median age) - pVL > 1000 - CD4 not limited |
48 | DRV/r (800 mg/d) |
DTG |
Molina JM45 | 96 | |||||||
IMEA 040 DATA trial | Slama L19 | 2011–2013 | France | 120 (61:59) | -Adult -43 y (median) - pVL > 1000 - CD4 < 200 |
48 | DRV/r (800 mg/d) |
ATV/r |
METABOLIK | Aberg JA46 | NA | US | 65 (34:31) | -36.5 y (median age) in the study group and 35.0 y in the control group -pVL > 1000 - CD4 not limited |
48 | DRV/r (800 mg/d) |
ATV/r |
NEAT001/ ANRS143 |
Raffi F47 | 2010–2011 | Europe | 805 (401:404) |
-37 y (median age) in the RAL group and 39 y (median) in the TDF-FTC group -pVL > 1000 - CD4 < 500 |
96 | DRV/r (800 mg/d) + TDF/FTC | RAL + DRV/R (800 mg/d) |
OPTIPRIM-ANRS 147 | Chéret A48 | 2010–2011 | France | 90 (45:45) |
-35 y (median age) - pVL not limited - CD4 < 500 |
96 | DRV/r (800 mg/d) + TDF/FTC | DRV/r (800 mg/d) + RAL/MVC + TDF/FTC |