title: Monotherapy with darunavir/ritonavir or lopinavir/ritonavir versus standard antiretroviral therapy: a randomized clinical trial (2pm Study).
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.
authors.affiliation: Malattie Infettive, IRCCS Ospedale San Raffaele, Milano, Italy.
authors.forename: Nicola
authors.initials: N
authors.lastname: Gianotti
authors.affiliation: Malattie Infettive, IRCCS Ospedale San Raffaele, Milano, Italy.
authors.forename: Laura
authors.initials: L
authors.lastname: Galli
authors.affiliation: Malattie Infettive, Fondazione IRCCS Policlinico San Matteo di Pavia, Italy.
authors.forename: Renato
authors.initials: R
authors.lastname: Maserati
authors.affiliation: U.O. Malattie Infettive, Azienda Ospedaliero Universitaria, Ferrara, Italy.
authors.forename: Laura
authors.initials: L
authors.lastname: Sighinolfi
authors.affiliation: Malattie Infettive, Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, Italy.
authors.forename: Diego
authors.initials: D
authors.lastname: Ripamonti
authors.affiliation: S.C. Malattie Infettive, Ospedale Carlo Poma, Mantova, Italy.
authors.forename: Loredana
authors.initials: L
authors.lastname: Palvarini
authors.affiliation: Malattie Infettive, Ospedale Santa Maria Annunziata, Firenze, Italy.
authors.forename: Sergio
authors.initials: S
authors.lastname: Lo Caputo
authors.affiliation: Dipartimento di Malattie Infettive e Tropicali, Università di Brescia, Spedali Civili, Brescia, Italy.
authors.forename: Emanuele
authors.initials: E
authors.lastname: Focà
authors.affiliation: Malattie Infettive, Azienda Ospedaliera Garibaldi, Catania, Italy.
authors.forename: Benedetto Maurizio
authors.initials: BM
authors.lastname: Celesia
authors.affiliation: Malattie Infettive, Azienda Ospedaliera di Perugia, Perugia, Italy.
authors.forename: Franco
authors.initials: F
authors.lastname: Baldelli
authors.affiliation: SOD di Malattie Infettive e Tropicali, Azienda Ospedaliero-Universitaria Careggi, Firenze, Italy.
authors.forename: Gaetana
authors.initials: G
authors.lastname: Sterrantino
authors.affiliation: Malattie Infettive, IRCCS Ospedale San Raffaele, Milano, Italy.|Università Vita-Salute San Raffaele, Milano, Italy.
authors.forename: Adriano
authors.initials: A
authors.lastname: Lazzarin
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000627:therapeutic use; D023241:Antiretroviral Therapy, Highly Active; D000069454:Darunavir / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D061466:Lopinavir / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D019438:Ritonavir / Q000008:administration & dosage / Q000627:therapeutic use*
chemical_list: D019380:Anti-HIV Agents; D061466:Lopinavir; D019438:Ritonavir; D000069454:Darunavir
keywords: Antiretroviral therapy; Darunavir/ritonavir; HIV PI/r monotherapy; Lopinavir/ ritonavir; Randomized clinical trial