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Randomized Controlled Trial
. 2016 Oct;39(4):290-294.
Epub 2016 Aug 23.

Monotherapy with darunavir/ritonavir or lopinavir/ritonavir versus standard antiretroviral therapy: a randomized clinical trial (2pm Study)

Nicola Gianotti  1 , Laura Galli  1 , Renato Maserati  2 , Laura Sighinolfi  3 , Diego Ripamonti  4 , Loredana Palvarini  5 , Sergio Lo Caputo  6 , Emanuele Focà  7 , Benedetto Maurizio Celesia  8 , Franco Baldelli  9 , Gaetana Sterrantino  10 , Adriano Lazzarin  1   11
Affiliations
  • PMID: 27551725
Free article
Randomized Controlled Trial

Monotherapy with darunavir/ritonavir or lopinavir/ritonavir versus standard antiretroviral therapy: a randomized clinical trial (2pm Study)

Nicola Gianotti et al. New Microbiol. 2016 Oct.
Free article

Abstract

In a multicentre, open-label, clinical trial, 43 patients virologically suppressed while receiving a standard triple antiretroviral therapy were randomized (1:1:1) to switch to monotherapy with darunavir/ritonavir (DRV/r-MT arm), monotherapy with lopinavir/ritonavir (LPV/r-MT arm) or to continue on the ongoing regimen (cART arm). The proportion (95% CI) of patients with virological success (Snapshot analysis) at week 48 was 73% (48%-90%) in the DRV/r-MT arm, 69% (42%-88%) in the LPV/r-MT arm and 87% (61%-98%) in the cART arm. Virological failure was detected in only one patient receiving LPV/r-MT. The LPV/r-MT arm showed a modest worsening in lipid profile.

Keywords: Antiretroviral therapy; Darunavir/ritonavir; HIV PI/r monotherapy; Lopinavir/ ritonavir; Randomized clinical trial.

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