Monteiro et al. [36]/2013/Yes
|
Observational
|
RAL + ETV
|
25
|
48
|
-91% virologically suppressed in per-protocol analysis
|
|
|
|
|
|
-Lipids improved
|
Ward et al. [26]/2013/No
|
Observational
|
Switching for toxicity concerns to a RAL + 1 or 2 agents, most commonly on RAL + ATV/r with or without ETV or MVC
|
62
|
168
|
-92% virologically suppressed;
|
|
|
-3 of 15 on dual therapy had to add third agent for low-level viremia
|
Calin et al. [27]/2013/No
|
Observational
|
Switching to RAL + ETV regimen
|
91
|
48
|
-93% had viral load <50 copies/mL
|
|
|
|
|
|
-4/5 with virological failures had past NNRTI mutations
|
|
|
|
|
|
-3 patients had RAL mutations
|
Katlama et al. [28], ROCnRAL/2013/No
|
Single-arm exploratory trial
|
R5-trophic suppressed patients switched to MVC + RAL
|
41
|
48
|
-Failure in 11.4%
|
|
|
-RAL mutations in 3/5 patients who failed
|
|
|
|
-1/5 had R5 to ×4 virus switch
|
Cotte et al. [29], No Nuc No Boost/2013/No
|
Single-arm exploratory trial
|
MVC + RAL
|
10
|
48
|
-No virological failures (>50 copies/mL)
|
|
|
|
-No serious adverse event
|
Burgos et al. [30]/2012/No
|
Observational
|
Switching for toxicity concerns to a PI/r + 2nd agent, many with no NRTI
|
131
|
56
|
- > 90% virologically suppressed.
|
Ofotokun et al. [31], KITE/2012/No
|
Exploratory pilot trial
|
(i) LPV/r + RAL; (ii) standard ART
|
60
|
48
|
-92% in arm (i) and 88% in arm (ii) with viral load <50 copies/mL;
|
|
|
|
|
|
-Higher triglycerides in arm (i)
|
|
|
|
|
|
-No difference in BMD or body composition.
|
Carey et al. [32], SPARTA/2012/Yes
|
Pilot cross-over RCT
|
Patients receiving ATV/r randomized to: (i) ATV/r (300/100 mg respectively once daily) + RAL (800 mg once daily)
|
25
|
76% in follow-up for 48 weeks
|
-Both agents pharmacologically compatible.
|
(ii) ATV (300 mg twice daily) + RAL (400 mg twice daily)
|
-All patients remained virologically suppressed
|
Cordery et al. [35]/2010/Yes
|
Observational
|
RAL + ATV (unboosted)
|
20
|
72
|
-Only 1 (5%) failure
|
Allavena et al. [33]/2009/Yes
|
Observational
|
Switching for toxicity concerns to a PI/r + RAL.
|
29
|
48
|
-100% virologically suppressed
|
Fischl et al. [34]/2007/Yes
|
RCT, not fully powered
|
(i) LPV/r + EFV;
|
236
|
96
|
-Arm (i): shorter time to failure or discontinuation;
|
(ii) EFV + NRTIs
|
|
|
|
|
|
-Arm (i): greater increase in triglycerides |