Pilot, Randomized Study Assessing Safety, Tolerability and Efficacy of Simplified LPV/r Maintenance Therapy in HIV Patients on the 1st PI-Based Regimen
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{"title"=>"Pilot, Randomized Study Assessing Safety, Tolerability and Efficacy of Simplified LPV/r Maintenance Therapy in HIV Patients on the 1st PI-Based Regimen", "type"=>"journal", "authors"=>[{"first_name"=>"Pedro", "last_name"=>"Cahn"}, {"first_name"=>"Julio", "last_name"=>"Montaner"}, {"first_name"=>"Patrice", "last_name"=>"Junod"}, {"first_name"=>"Patricia", "last_name"=>"Patterson"}, {"first_name"=>"Alejandro", "last_name"=>"Krolewiecki"}, {"first_name"=>"Jaime", "last_name"=>"Andrade-Villanueva"}, {"first_name"=>"Isabel", "last_name"=>"Cassetti"}, {"first_name"=>"Juan", "last_name"=>"Sierra-Madero"}, {"first_name"=>"Arnaldo David", "last_name"=>"Casiró"}, {"first_name"=>"Raul", "last_name"=>"Bortolozzi"}, {"first_name"=>"Sergio Horacio", "last_name"=>"Lupo"}, {"first_name"=>"Nadia", "last_name"=>"Longo"}, {"first_name"=>"Emmanouil", "last_name"=>"Rampakakis"}, {"first_name"=>"Nabil", "last_name"=>"Ackad"}, {"first_name"=>"John S.", "last_name"=>"Sampalis"}], "year"=>2011, "source"=>"PLoS ONE", "identifiers"=>{"doi"=>"10.1371/journal.pone.0023726", "issn"=>"1932-6203"}, "id"=>"3e12d872-5dd7-38e0-b6d5-d92c87fa561e", "link"=>"http://www.mendeley.com/research/pilot-randomized-study-assessing-safety-tolerability-efficacy-simplified-lpvr-maintenance-therapy-hi", "reader_count"=>6, "reader_count_by_academic_status"=>{"Student > Master"=>6}, "reader_count_by_user_role"=>{"Student > Master"=>6}, "reader_count_by_subject_area"=>{"Nursing and Health Professions"=>1, "Mathematics"=>5}, "reader_count_by_subdiscipline"=>{"Nursing and Health Professions"=>{"Nursing and Health Professions"=>1}, "Mathematics"=>{"Mathematics"=>5}}, "group_count"=>0}

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Figshare

  • {"files"=>["https://ndownloader.figshare.com/files/744267"], "description"=>"1<p><i>Based on student's t-test for independent samples</i>.</p>", "links"=>[], "tags"=>["immunologic"], "article_id"=>414624, "categories"=>["Pharmacology", "Virology", "Infectious Diseases", "Immunology"], "users"=>["Pedro Cahn", "Julio Montaner", "Patrice Junod", "Patricia Patterson", "Alejandro Krolewiecki", "Jaime Andrade-Villanueva", "Isabel Cassetti", "Juan Sierra-Madero", "Arnaldo David Casiró", "Raul Bortolozzi", "Sergio Horacio Lupo", "Nadia Longo", "Emmanouil Rampakakis", "Nabil Ackad", "John S. Sampalis"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0023726.t002", "stats"=>{"downloads"=>0, "page_views"=>1, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Virologic_and_Immunologic_Response_/414624", "title"=>"Virologic and Immunologic Response.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2011-08-19 01:17:04"}
  • {"files"=>["https://ndownloader.figshare.com/files/376414", "https://ndownloader.figshare.com/files/376546"], "description"=>"<div><h3>Objectives</h3><p>To compare the efficacy and safety of an individualized treatment-simplification strategy consisting of switching from a highly-active anti-retroviral treatment (HAART) with a ritonavir-boosted protease inhibitor (PI/r) and 2 nucleoside reverse-transcriptase inhibitors (NRTIs) to lopinavir/ritonavir (LPV/r) monotherapy, with intensification by 2 NRTIs if necessary, to that of continuing their HAART.</p> <h3>Methods</h3><p>This is a one-year, randomized, open-label, multi-center study in virologically-suppressed HIV-1-infected adults on their first PI/r-containing treatment, randomized to either LPV/r-monotherapy or continue their current treatment. Treatment efficacy was determined by plasma HIV-1 RNA viral load (VL), time-to-virologic rebound, patient-reported outcomes (PROs) and CD4+T-cell-count changes. Safety was assessed with the incidence of treatment-emergent adverse events (AE).</p> <h3>Results</h3><p>Forty-one patients were randomized to LPV/r and 39 to continue their HAART. No statistically-significant differences between the two study groups in demographics and baseline characteristics were observed. At day-360, 71(39:LPV/r;32:HAART) patients completed treatment, while 9(2:LPV/r;7:HAART) discontinued. In a Last Observation Carried Forward Intent-to-Treat analysis, 40(98%) patients on LPV/r and 37(95%) on HAART had VL<200copies/mL (P = 0.61). Time-to-virologic rebound, changes in PROs, CD4+ T-cell-count and VL from baseline, also exhibited no statistically-significant between-group differences. Most frequent AEs were diarrhea (19%), headache (18%) and influenza (16%). Four (10%) patients on LPV/r were intensified with 2 NRTIs, all regaining virologic control. Eight serious AEs were reported by 5(2:LPV/r;3:HAART) patients.</p> <h3>Conclusion</h3><p>At day-360, virologic efficacy and safety of LPV/r appears comparable to that of a PI+2NRTIs HAART. These results suggest that our individualized, simplified maintenance strategy with LPV/r-monotherapy and protocol-mandated NRTI re-introduction upon viral rebound, in virologically-suppressed patients merits further prospective long-term evaluation.</p> <h3>Trial Registration</h3><p>ClinicalTrials.gov <a href=\"http://www.clinicaltrials.gov/ct2/results?term=NCT00159224\">NCT00159224</a></p> </div>", "links"=>[], "tags"=>["randomized", "assessing", "tolerability", "efficacy", "simplified", "hiv", "patients", "pi-based", "regimen"], "article_id"=>134355, "categories"=>["Cancer", "Pharmacology", "Immunology"], "users"=>["Pedro Cahn", "Julio Montaner", "Patrice Junod", "Patricia Patterson", "Alejandro Krolewiecki", "Jaime Andrade-Villanueva", "Isabel Cassetti", "Juan Sierra-Madero", "Arnaldo David Casiró", "Raul Bortolozzi", "Sergio Horacio Lupo", "Nadia Longo", "Emmanouil Rampakakis", "Nabil Ackad", "John S. Sampalis"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0023726.s001", "https://dx.doi.org/10.1371/journal.pone.0023726.s002"], "stats"=>{"downloads"=>6, "page_views"=>10, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/Pilot_Randomized_Study_Assessing_Safety_Tolerability_and_Efficacy_of_Simplified_LPV_r_Maintenance_Therapy_in_HIV_Patients_on_the_1_st_PI_Based_Regimen/134355", "title"=>"Pilot, Randomized Study Assessing Safety, Tolerability and Efficacy of Simplified LPV/r Maintenance Therapy in HIV Patients on the 1<sup>st</sup> PI-Based Regimen", "pos_in_sequence"=>0, "defined_type"=>4, "published_date"=>"2011-08-19 01:12:35"}
  • {"files"=>["https://ndownloader.figshare.com/files/744093"], "description"=>"<p>\n <i><sup>1</sup> Dotted lines represent the linear regression function based on the least squares method. <sup>2</sup> SDM, Symptoms Distress Module; ▪, Standard Treatment; ♦, Induction/Maintenance. * P-value for between-group difference in change over time based on Repeated Measures Analysis of Variance <sup>†</sup> P-value for within-group change over time based on linear regression analysis.</i></p>", "links"=>[], "tags"=>["follow-up"], "article_id"=>414456, "categories"=>["Pharmacology", "Virology", "Infectious Diseases", "Immunology"], "users"=>["Pedro Cahn", "Julio Montaner", "Patrice Junod", "Patricia Patterson", "Alejandro Krolewiecki", "Jaime Andrade-Villanueva", "Isabel Cassetti", "Juan Sierra-Madero", "Arnaldo David Casiró", "Raul Bortolozzi", "Sergio Horacio Lupo", "Nadia Longo", "Emmanouil Rampakakis", "Nabil Ackad", "John S. Sampalis"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0023726.g003", "stats"=>{"downloads"=>1, "page_views"=>6, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_PROs_by_Treatment_Group_and_Follow_Up_Visits_/414456", "title"=>"PROs by Treatment Group and Follow-Up Visits.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2011-08-19 01:14:16"}
  • {"files"=>["https://ndownloader.figshare.com/files/743851"], "description"=>"<p>\n <i>* ST: Standard Treatment; IM: Induction/Maintenance.</i></p>", "links"=>[], "tags"=>["Virology", "immunology", "Infectious diseases", "pharmacology"], "article_id"=>414201, "categories"=>["Pharmacology", "Virology", "Infectious Diseases", "Immunology"], "users"=>["Pedro Cahn", "Julio Montaner", "Patrice Junod", "Patricia Patterson", "Alejandro Krolewiecki", "Jaime Andrade-Villanueva", "Isabel Cassetti", "Juan Sierra-Madero", "Arnaldo David Casiró", "Raul Bortolozzi", "Sergio Horacio Lupo", "Nadia Longo", "Emmanouil Rampakakis", "Nabil Ackad", "John S. Sampalis"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0023726.g001", "stats"=>{"downloads"=>0, "page_views"=>5, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Patient_Disposition_/414201", "title"=>"Patient Disposition.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2011-08-19 01:10:01"}
  • {"files"=>["https://ndownloader.figshare.com/files/744218"], "description"=>"<p>Patient Demographics and Baseline Characteristics in the ITT population.</p>", "links"=>[], "tags"=>["demographics", "baseline", "characteristics", "itt"], "article_id"=>414575, "categories"=>["Pharmacology", "Virology", "Infectious Diseases", "Immunology"], "users"=>["Pedro Cahn", "Julio Montaner", "Patrice Junod", "Patricia Patterson", "Alejandro Krolewiecki", "Jaime Andrade-Villanueva", "Isabel Cassetti", "Juan Sierra-Madero", "Arnaldo David Casiró", "Raul Bortolozzi", "Sergio Horacio Lupo", "Nadia Longo", "Emmanouil Rampakakis", "Nabil Ackad", "John S. Sampalis"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0023726.t001", "stats"=>{"downloads"=>0, "page_views"=>1, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Patient_Demographics_and_Baseline_Characteristics_in_the_ITT_population_/414575", "title"=>"Patient Demographics and Baseline Characteristics in the ITT population.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2011-08-19 01:16:15"}
  • {"files"=>["https://ndownloader.figshare.com/files/743991"], "description"=>"<p>(a): >200 HIV-1 RNA copies / ml. (b): >50 HIV-1 RNA copies / ml.<i>* Censored observations represent patients who exited the study without experiencing virologic rebound</i>.</p>", "links"=>[], "tags"=>["meier", "confirmed", "virologic"], "article_id"=>414351, "categories"=>["Pharmacology", "Virology", "Infectious Diseases", "Immunology"], "users"=>["Pedro Cahn", "Julio Montaner", "Patrice Junod", "Patricia Patterson", "Alejandro Krolewiecki", "Jaime Andrade-Villanueva", "Isabel Cassetti", "Juan Sierra-Madero", "Arnaldo David Casiró", "Raul Bortolozzi", "Sergio Horacio Lupo", "Nadia Longo", "Emmanouil Rampakakis", "Nabil Ackad", "John S. Sampalis"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0023726.g002", "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Kaplan_Meier_Analysis_for_time_to_confirmed_virologic_rebound_/414351", "title"=>"Kaplan Meier Analysis for time to confirmed virologic rebound.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2011-08-19 01:12:31"}

PMC Usage Stats | Further Information

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  • {"unique-ip"=>"17", "full-text"=>"13", "pdf"=>"9", "abstract"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"1", "supp-data"=>"5", "cited-by"=>"0", "year"=>"2015", "month"=>"9"}
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  • {"unique-ip"=>"11", "full-text"=>"9", "pdf"=>"3", "abstract"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"3", "supp-data"=>"1", "cited-by"=>"0", "year"=>"2014", "month"=>"9"}
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Relative Metric

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