OBJECTIVES: We evaluated a monotherapy maintenance regimen with lopinavir/ritonavir versus continuing current combined antiretroviral treatment (cART) in HIV patients with suppressed plasma HIV-1 RNA. PATIENTS AND METHODS: This was an open-label, non-inferiority, multicentre trial in 23 sites in France. Adults were randomized if they had no history of virological failure while receiving a protease inhibitor, maintained HIV-1 RNA <50 copies/mL for at least 6 months and did not change cART during the last 3 months. The primary endpoint was the proportion of patients with HIV-1 RNA <50 copies/mL at Week 48 (non-inferiority margin set at -12%) with missing data and treatment modification considered as failure. The trial has been registered in ClinicalTrials.gov under the identifier NCT00140751. RESULTS: At Week 48, 84% (73/87) of patients in the lopinavir/ritonavir monotherapy group met the primary endpoint compared with 88% (87/99) in the cART group [difference, -4.0%, lower limit of 90% two-sided confidence interval (CI) for difference, -12.4%]. In secondary analysis with success defined as plasma HIV-1 RNA <400 copies/mL, 87% (76/87) of patients in the lopinavir/ritonavir monotherapy group were virologically suppressed compared with 88% (87/99) in the cART group (difference, -0.5%, lower limit of 90% two-sided CI for difference, -8.5%). If antiretroviral treatment intensification was taken into account, 91% (79/87) of patients in the lopinavir/ritonavir monotherapy group met the primary endpoint compared with 88% (87/99) in the cART group (difference, +2.9%, lower limit of 90% two-sided CI for difference, -4.5%). Failures of lopinavir/ritonavir monotherapy did not show acquired resistance mutations in the protease gene. CONCLUSIONS:Lopinavir/ritonavir monotherapy did not achieve non-inferiority versus cART for maintaining plasma HIV-1 RNA <50 copies/mL. Nevertheless, the incidence of virological failure was low (mostly with HIV-1 RNA <400 copies/mL) and easily managed by treatment intensification.
RCT Entities:
OBJECTIVES: We evaluated a monotherapy maintenance regimen with lopinavir/ritonavir versus continuing current combined antiretroviral treatment (cART) in HIV patients with suppressed plasma HIV-1 RNA. PATIENTS AND METHODS: This was an open-label, non-inferiority, multicentre trial in 23 sites in France. Adults were randomized if they had no history of virological failure while receiving a protease inhibitor, maintained HIV-1 RNA <50 copies/mL for at least 6 months and did not change cART during the last 3 months. The primary endpoint was the proportion of patients with HIV-1 RNA <50 copies/mL at Week 48 (non-inferiority margin set at -12%) with missing data and treatment modification considered as failure. The trial has been registered in ClinicalTrials.gov under the identifier NCT00140751. RESULTS: At Week 48, 84% (73/87) of patients in the lopinavir/ritonavir monotherapy group met the primary endpoint compared with 88% (87/99) in the cART group [difference, -4.0%, lower limit of 90% two-sided confidence interval (CI) for difference, -12.4%]. In secondary analysis with success defined as plasma HIV-1 RNA <400 copies/mL, 87% (76/87) of patients in the lopinavir/ritonavir monotherapy group were virologically suppressed compared with 88% (87/99) in the cART group (difference, -0.5%, lower limit of 90% two-sided CI for difference, -8.5%). If antiretroviral treatment intensification was taken into account, 91% (79/87) of patients in the lopinavir/ritonavir monotherapy group met the primary endpoint compared with 88% (87/99) in the cART group (difference, +2.9%, lower limit of 90% two-sided CI for difference, -4.5%). Failures of lopinavir/ritonavir monotherapy did not show acquired resistance mutations in the protease gene. CONCLUSIONS:Lopinavir/ritonavir monotherapy did not achieve non-inferiority versus cART for maintaining plasma HIV-1 RNA <50 copies/mL. Nevertheless, the incidence of virological failure was low (mostly with HIV-1 RNA <400 copies/mL) and easily managed by treatment intensification.
Authors: Maximilian Donath; Timo Wolf; Martin Stürmer; Eva Herrmann; Markus Bickel; Pavel Khaykin; Siri Göpel; Peter Gute; Annette Haberl; Philipp de Leuw; Gundolf Schüttfort; Annemarie Berger; Christoph Stephan Journal: Med Microbiol Immunol Date: 2016-07-28 Impact factor: 3.402
Authors: Adrian V Hernandez; Vinay Pasupuleti; Abhishek Deshpande; Priyaleela Thota; Jaime A Collins; Jose E Vidal Journal: PLoS One Date: 2013-05-03 Impact factor: 3.240
Authors: Luis F López-Cortés; Manuel A Castaño; Miguel A López-Ruz; María J Rios-Villegas; José Hernández-Quero; Dolores Merino; Patricia Jiménez-Aguilar; Manuel Marquez-Solero; Alberto Terrón-Pernía; Francisco Tellez-Pérez; Pompeyo Viciana; Francisco Orihuela-Cañadas; Zaira Palacios-Baena; David Vinuesa-Garcia; Jose M Fajardo-Pico; Alberto Romero-Palacios; Guillermo Ojeda-Burgos; Juan Pasquau-Liaño Journal: PLoS One Date: 2016-02-12 Impact factor: 3.240
Authors: Sidonie Lambert-Niclot; Philippe Flandre; Marc-Antoine Valantin; Cathia Soulie; Slim Fourati; Marc Wirden; Sophie Sayon; Sophie Pakianather; Laurence Bocket; Bernard Masquelier; Georges Dos Santos; Christine Katlama; Vincent Calvez; Anne-Genevieve Marcelin Journal: PLoS One Date: 2012-07-25 Impact factor: 3.240