Randomized controlled trial of once-daily tenofovir, lamivudine, and lopinavir/ritonavir versus remaining on the same regimen in virologically suppressed HIV-infected patients on their first PI-containing HAART regimen.
OBJECTIVE
To assess the effects of switching to once-daily (QD) lopinavir/ritonavir (LPV/r)-based combination therapy in HIV-infected patients who are virologically suppressed (HIV viral load <50 copies/mL) on their first protease inhibitor (PI)-containing regimen.


METHODS
In this 48-week, prospective, open-label, randomized study, patients were either switched to once-daily LPV/r, tenofovir (TDF), and lamivudine (3TC) (QD arm) or remained on their existing regimen (control arm). The primary endpoint of the study was the proportion of patients maintaining virologic suppression following 48 weeks of treatment.


RESULTS
Fifty and 22 patients were randomized to the QD and control arms, respectively. At week 48, there was no significant difference in virological suppression between the QD and control arms using intent-to-treat (missing = failure) analysis (p = .44). There was no significant difference in discontinuation rates between the two arms (p = .66). Significantly more patients randomized to the QD arm reported gastrointestinal adverse events compared with the control arm (p = .009). There were no study drug-related serious adverse events.


CONCLUSIONS
For patients who are already virologically suppressed on their first PI-containing regimen, switching to a QD regimen of TDF+3TC+LPV/r resulted in similar rates of virologic suppression when compared with staying on existing therapy.
Loutfy
Mona R
MR
Department of Medicine, University of Toronto, Toronto, Canada.
Ackad
Nabil
N
Antoniou
Tony
T
Baril
Jean-Guy
JG
Conway
Brian
B
de Wet
Joss
J
Trottier
Benoit
B
Kovacs
Colin M
CM
Thompson
William
W
Martel
Alain Y
AY
Trottier
Sylvie
S
Rouleau
Danielle
D
Shafran
Stephen D
SD
Rachlis
Anita
A
Fraser
Christopher
C
Smaill
Fiona
F
Walmsley
Sharon L
SL
Tseng
Alice L
AL
Sampalis
John S
JS
D000225:Adenine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000328:Adult; D023241:Antiretroviral Therapy, Highly Active; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D017320:HIV Protease Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D019259:Lamivudine / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D061466:Lopinavir; D008297:Male; D008875:Middle Aged; D063065:Organophosphonates / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D011744:Pyrimidinones / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D019438:Ritonavir / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D000068698:Tenofovir; D019562:Viral Load
D017320:HIV Protease Inhibitors; D063065:Organophosphonates; D011744:Pyrimidinones; D061466:Lopinavir; D019259:Lamivudine; D000068698:Tenofovir; D000225:Adenine; D019438:Ritonavir