Boyd et al. [18], SECOND-LINE/2013/Yes
|
Phase-3/4 RCT, non-inferiority
|
(i) LPV/r + RAL vs. (ii) LPV/r + recycled NRTIs in those failing 1st line NNRTI-based ART
|
541 (271 vs. 270)
|
48
|
-Arm (i) non-inferior to arm (ii) for virological outcome
|
|
|
|
|
|
-No major differences in serious adverse events
|
-Greater decline in BMD in arm (ii) [25]
|
Paton et al. [19], EARNEST/2013/No
|
Phase-3/4 RCT, non-inferiority
|
(i) LPV/r + RAL
|
(i) 433; (ii) 418; (iii) 426
|
96
|
-Arm (i) non-inferior to arm (iii) for a composite of virological and clinical endpoint
|
(ii) LPV/r monotherapy after induction with LPV/r + RAL
|
|
|
(iii) LPV/r + recycled NRTIs (control) in those failing 1st line NNRTI-based ART
|
|
|
-Arm (ii) inferior to other arms for virological outcome and higher LPV/r resistance
|
|
|
|
|
|
-No differences in grade 3/4 events
|
Tashima et al. [20], OPTIONS/2013/No
|
Phase-3/4 RCT, non-inferiority
|
(i) NRTI-omitting optimised regimen
|
(i) 179; (ii) 181
|
48
|
-Similar virlogical outcomes in both arms
|
(ii) NRTI-including optimised regimen in triple-class experienced failing patients
|
|
|
-No differences in grade 3/4 events
|
-Higher mortality in arm (ii).
|
Ruane et al. [24], INROADS/2013/No
|
Single-arm exploratory phase-2b trial
|
DRV/r + ETV in failing patients (78%) or ART naïve patients with transmitted resistance (22%)
|
54 (75% completed the study)
|
48
|
-100% of ART naïve and 87% of failing patients achieved virological success.
|
-2 patients developed ETV mutations and none had DRV mutations.
|
Imaz et al. [21]/2011/Yes
|
Observational
|
Salvage regimen of at least three active agents from DRV, ETV, RAL and MVC, with or without NRTIs
|
122
|
48
|
-78% virologically suppressed (equal in both arms)
|
-Higher baseline viral load associated with worse outcomes.
|
Nozza et al. [22]/2011/Yes
|
Observational
|
Salvage regimen of RAL + MVC + ETV
|
28
|
96
|
-96% virologically suppressed (<50 copies/ml)
|
Florence et al. [23]/2010/Yes |
Observational |
Salvage regimen of ETV + optimised regimen, 40% without NRTIs |
941 |
24 |
-70% and 90% had viral load <50 and 400 copies/mL respectively. |