No Treatment versus 24 or 60 Weeks of Antiretroviral Treatment during Primary HIV Infection: The Randomized Primo-SHM Trial
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{"title"=>"No treatment versus 24 or 60 weeks of antiretroviral treatment during primary HIV infection: The randomized primo-SHM trial", "type"=>"journal", "authors"=>[{"first_name"=>"Marlous L.", "last_name"=>"Grijsen", "scopus_author_id"=>"25225113700"}, {"first_name"=>"Radjin", "last_name"=>"Steingrover", "scopus_author_id"=>"8695292400"}, {"first_name"=>"Ferdinand W.N.M.", "last_name"=>"Wit", "scopus_author_id"=>"6701695606"}, {"first_name"=>"Suzanne", "last_name"=>"Jurriaans", "scopus_author_id"=>"7003668619"}, {"first_name"=>"Annelies", "last_name"=>"Verbon", "scopus_author_id"=>"7003819138"}, {"first_name"=>"Kees", "last_name"=>"Brinkman", "scopus_author_id"=>"56883023300"}, {"first_name"=>"Marchina E.", "last_name"=>"van der Ende", "scopus_author_id"=>"35445430200"}, {"first_name"=>"Robin", "last_name"=>"Soetekouw", "scopus_author_id"=>"35520509600"}, {"first_name"=>"Frank", "last_name"=>"de Wolf", "scopus_author_id"=>"7005022848"}, {"first_name"=>"Joep M.A.", "last_name"=>"Lange", "scopus_author_id"=>"55940262000"}, {"first_name"=>"Hanneke", "last_name"=>"Schuitemaker", "scopus_author_id"=>"7006687551"}, {"first_name"=>"Jan M.", "last_name"=>"Prins", "scopus_author_id"=>"7102303470"}], "year"=>2012, "source"=>"PLoS Medicine", "identifiers"=>{"issn"=>"15491277", "scopus"=>"2-s2.0-84858958596", "pui"=>"364514783", "doi"=>"10.1371/journal.pmed.1001196", "isbn"=>"1549-1676 (Electronic)\\r1549-1277 (Linking)", "sgr"=>"84858958596", "pmid"=>"22479156"}, "id"=>"4e4336f0-5357-3785-a081-b3969dd8796a", "abstract"=>"BACKGROUND: The objective of this study was to assess the benefit of temporary combination antiretroviral therapy (cART) during primary HIV infection (PHI).\\n\\nMETHODS AND FINDINGS: Adult patients with laboratory evidence of PHI were recruited in 13 HIV treatment centers in the Netherlands and randomly assigned to receive no treatment or 24 or 60 wk of cART (allocation in a 1∶1∶1 ratio); if therapy was clinically indicated, participants were randomized over the two treatment arms (allocation in a 1∶1 ratio). Primary end points were (1) viral set point, defined as the plasma viral load 36 wk after randomization in the no treatment arm and 36 wk after treatment interruption in the treatment arms, and (2) the total time that patients were off therapy, defined as the time between randomization and start of cART in the no treatment arm, and the time between treatment interruption and restart of cART in the treatment arms. cART was (re)started in case of confirmed CD4 cell count < 350 cells/mm(3) or symptomatic HIV disease. In total, 173 participants were randomized. The modified intention-to-treat analysis comprised 168 patients: 115 were randomized over the three study arms, and 53 randomized over the two treatment arms. Of the 115 patients randomized over the three study arms, mean viral set point was 4.8 (standard deviation 0.6) log(10) copies/ml in the no treatment arm, and 4.0 (1.0) and 4.3 (0.9) log(10) copies/ml in the 24- and 60-wk treatment arms (between groups: p < 0.001). The median total time off therapy in the no treatment arm was 0.7 (95% CI 0.0-1.8) y compared to 3.0 (1.9-4.2) and 1.8 (0.5-3.0) y in the 24- and 60-wk treatment arms (log rank test, p < 0.001). In the adjusted Cox analysis, both 24 wk (hazard ratio 0.42 [95% CI 0.25-0.73]) and 60 wk of early treatment (hazard ratio 0.55 [0.32-0.95]) were associated with time to (re)start of cART.\\n\\nCONCLUSIONS: In this trial, temporary cART during PHI was found to transiently lower the viral set point and defer the restart of cART during chronic HIV infection.", "link"=>"http://www.mendeley.com/research/treatment-versus-24-60-weeks-antiretroviral-treatment-during-primary-hiv-infection-randomized-primos", "reader_count"=>40, "reader_count_by_academic_status"=>{"Professor > Associate Professor"=>2, "Librarian"=>1, "Researcher"=>11, "Student > Doctoral Student"=>2, "Student > Ph. D. Student"=>11, "Student > Postgraduate"=>3, "Student > Master"=>3, "Other"=>3, "Student > Bachelor"=>1, "Professor"=>3}, "reader_count_by_user_role"=>{"Professor > Associate Professor"=>2, "Librarian"=>1, "Researcher"=>11, "Student > Doctoral Student"=>2, "Student > Ph. D. Student"=>11, "Student > Postgraduate"=>3, "Student > Master"=>3, "Other"=>3, "Student > Bachelor"=>1, "Professor"=>3}, "reader_count_by_subject_area"=>{"Engineering"=>1, "Unspecified"=>2, "Environmental Science"=>1, "Biochemistry, Genetics and Molecular Biology"=>1, "Medicine and Dentistry"=>23, "Agricultural and Biological Sciences"=>3, "Pharmacology, Toxicology and Pharmaceutical Science"=>1, "Physics and Astronomy"=>1, "Social Sciences"=>3, "Computer Science"=>2, "Immunology and Microbiology"=>2}, "reader_count_by_subdiscipline"=>{"Engineering"=>{"Engineering"=>1}, "Medicine and Dentistry"=>{"Medicine and Dentistry"=>23}, "Social Sciences"=>{"Social Sciences"=>3}, "Physics and Astronomy"=>{"Physics and Astronomy"=>1}, "Immunology and Microbiology"=>{"Immunology and Microbiology"=>2}, "Agricultural and Biological Sciences"=>{"Agricultural and Biological Sciences"=>3}, "Computer Science"=>{"Computer Science"=>2}, "Biochemistry, Genetics and Molecular Biology"=>{"Biochemistry, Genetics and Molecular Biology"=>1}, "Unspecified"=>{"Unspecified"=>2}, "Environmental Science"=>{"Environmental Science"=>1}, "Pharmacology, Toxicology and Pharmaceutical Science"=>{"Pharmacology, Toxicology and Pharmaceutical Science"=>1}}, "reader_count_by_country"=>{"Canada"=>1, "Argentina"=>1, "Belgium"=>1, "Italy"=>2, "Australia"=>1, "India"=>1}, "group_count"=>3}

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Figshare

  • {"files"=>["https://ndownloader.figshare.com/files/664000"], "description"=>"<p>Modeled mean pVL (A) and CD4 cell count (B) over time after randomization/TI in the no treatment and the 24- and 60-wk treatment arms for the group of patients randomized over the three study arms. Graphs show the estimates (± standard error of the mean) from the linear mixed models. The box below each graph shows the number of pVL and CD4 cell count measurements at each time point used for fitting the linear mixed models. c/ml, copies/ml.</p>", "links"=>[], "tags"=>["viral", "cd4", "interruption"], "article_id"=>334471, "categories"=>["Infectious Diseases"], "users"=>["Marlous L. Grijsen", "Radjin Steingrover", "Ferdinand W. N. M. Wit", "Suzanne Jurriaans", "Annelies Verbon", "Kees Brinkman", "Marchina E. van der Ende", "Robin Soetekouw", "Frank de Wolf", "Joep M. A. Lange", "Hanneke Schuitemaker", "Jan M. Prins"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001196.g002", "stats"=>{"downloads"=>1, "page_views"=>6, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Plasma_viral_load_and_CD4_cell_count_after_randomization_treatment_interruption_in_the_no_treatment_and_treatment_arms_/334471", "title"=>"Plasma viral load and CD4 cell count after randomization/treatment interruption in the no treatment and treatment arms.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2012-03-27 01:14:31"}
  • {"files"=>["https://ndownloader.figshare.com/files/664165"], "description"=>"<p>Kaplan-Meier curves of the probability of remaining off treatment for the no treatment arm versus the 24- and 60-wk treatment arms in the patients randomized over the three study arms using the mITT population (A), and for the 24- versus 60-wk treatment arms, including both treated patients randomized over all three study arms and patients randomized over the two treatment arms, using the per protocol population (B).</p>", "links"=>[], "tags"=>["Infectious diseases"], "article_id"=>334644, "categories"=>["Infectious Diseases"], "users"=>["Marlous L. Grijsen", "Radjin Steingrover", "Ferdinand W. N. M. Wit", "Suzanne Jurriaans", "Annelies Verbon", "Kees Brinkman", "Marchina E. van der Ende", "Robin Soetekouw", "Frank de Wolf", "Joep M. A. Lange", "Hanneke Schuitemaker", "Jan M. Prins"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001196.g003", "stats"=>{"downloads"=>0, "page_views"=>11, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Probability_of_remaining_off_treatment_in_the_no_treatment_and_treatment_arms_/334644", "title"=>"Probability of remaining off treatment in the no treatment and treatment arms.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2012-03-27 01:17:24"}
  • {"files"=>["https://ndownloader.figshare.com/files/664343"], "description"=>"a<p>Per protocol analysis excludes patients who discontinued cART earlier than planned and patients who did not interrupt cART but instead elected to continue cART for reasons other than a low CD4 count or symptomatic disease.</p>b<p>Hazard ratio (95% CI) for early cART; the reference group is the no treatment arm.</p>c<p>Hazard ratio (95% CI) per 100 CD4 cells/mm<sup>3</sup> increase.</p>d<p>Hazard ratio (95% CI) per 1 log<sub>10</sub> copies/ml increase.</p>", "links"=>[], "tags"=>["cox", "proportional", "models"], "article_id"=>334818, "categories"=>["Infectious Diseases"], "users"=>["Marlous L. Grijsen", "Radjin Steingrover", "Ferdinand W. N. M. Wit", "Suzanne Jurriaans", "Annelies Verbon", "Kees Brinkman", "Marchina E. van der Ende", "Robin Soetekouw", "Frank de Wolf", "Joep M. A. Lange", "Hanneke Schuitemaker", "Jan M. Prins"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001196.t002", "stats"=>{"downloads"=>4, "page_views"=>10, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Propensity_score_weighted_Cox_proportional_hazard_models_for_time_to_re_start_of_cART_/334818", "title"=>"Propensity-score-weighted Cox proportional hazard models for time to (re)start of cART.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2012-03-27 01:20:18"}
  • {"files"=>["https://ndownloader.figshare.com/files/664293"], "description"=>"<p>Data are <i>n</i> (percent) unless indicated otherwise.</p>a<p>16 patients with missing data.</p>b<p>51 patients with missing data.</p>c<p>65 patients with missing data.</p>d<p>60 patients with missing data.</p><p>MSM, men who have sex with men; n.a., not applicable.</p>", "links"=>[], "tags"=>["characteristics", "115", "patients", "randomized"], "article_id"=>334763, "categories"=>["Infectious Diseases"], "users"=>["Marlous L. Grijsen", "Radjin Steingrover", "Ferdinand W. N. M. Wit", "Suzanne Jurriaans", "Annelies Verbon", "Kees Brinkman", "Marchina E. van der Ende", "Robin Soetekouw", "Frank de Wolf", "Joep M. A. Lange", "Hanneke Schuitemaker", "Jan M. Prins"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001196.t001", "stats"=>{"downloads"=>1, "page_views"=>10, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Baseline_characteristics_of_115_patients_randomized_over_three_study_arms_/334763", "title"=>"Baseline characteristics of 115 patients randomized over three study arms.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2012-03-27 01:19:23"}
  • {"files"=>["https://ndownloader.figshare.com/files/340180", "https://ndownloader.figshare.com/files/340253", "https://ndownloader.figshare.com/files/340399"], "description"=>"<div><h3>Background</h3><p>The objective of this study was to assess the benefit of temporary combination antiretroviral therapy (cART) during primary HIV infection (PHI).</p> <h3>Methods and Findings</h3><p>Adult patients with laboratory evidence of PHI were recruited in 13 HIV treatment centers in the Netherlands and randomly assigned to receive no treatment or 24 or 60 wk of cART (allocation in a 1∶1∶1 ratio); if therapy was clinically indicated, participants were randomized over the two treatment arms (allocation in a 1∶1 ratio). Primary end points were (1) viral set point, defined as the plasma viral load 36 wk after randomization in the no treatment arm and 36 wk after treatment interruption in the treatment arms, and (2) the total time that patients were off therapy, defined as the time between randomization and start of cART in the no treatment arm, and the time between treatment interruption and restart of cART in the treatment arms. cART was (re)started in case of confirmed CD4 cell count <350 cells/mm<sup>3</sup> or symptomatic HIV disease. In total, 173 participants were randomized. The modified intention-to-treat analysis comprised 168 patients: 115 were randomized over the three study arms, and 53 randomized over the two treatment arms. Of the 115 patients randomized over the three study arms, mean viral set point was 4.8 (standard deviation 0.6) log<sub>10</sub> copies/ml in the no treatment arm, and 4.0 (1.0) and 4.3 (0.9) log<sub>10</sub> copies/ml in the 24- and 60-wk treatment arms (between groups: <em>p</em><0.001). The median total time off therapy in the no treatment arm was 0.7 (95% CI 0.0–1.8) y compared to 3.0 (1.9–4.2) and 1.8 (0.5–3.0) y in the 24- and 60-wk treatment arms (log rank test, <em>p</em><0.001). In the adjusted Cox analysis, both 24 wk (hazard ratio 0.42 [95% CI 0.25–0.73]) and 60 wk of early treatment (hazard ratio 0.55 [0.32–0.95]) were associated with time to (re)start of cART.</p> <h3>Conclusions</h3><p>In this trial, temporary cART during PHI was found to transiently lower the viral set point and defer the restart of cART during chronic HIV infection.</p> <h3>Trial registration</h3><p>Current Controlled Trials <a href=\"http://www.controlled-trials.com/ISRCTN59497461\">ISRCTN59497461</a></p> <h3></h3><p> <em>Please see later in the article for the Editors' Summary</em></p> </div>", "links"=>[], "tags"=>["24", "60", "weeks", "antiretroviral", "hiv", "randomized", "primo-shm"], "article_id"=>127236, "categories"=>["Cancer"], "users"=>["Marlous L. Grijsen", "Radjin Steingrover", "Ferdinand W. N. M. Wit", "Suzanne Jurriaans", "Annelies Verbon", "Kees Brinkman", "Marchina E. van der Ende", "Robin Soetekouw", "Frank de Wolf", "Joep M. A. Lange", "Hanneke Schuitemaker", "Jan M. Prins"], "doi"=>["https://dx.doi.org/10.1371/journal.pmed.1001196.s001", "https://dx.doi.org/10.1371/journal.pmed.1001196.s002", "https://dx.doi.org/10.1371/journal.pmed.1001196.s003"], "stats"=>{"downloads"=>16, "page_views"=>8, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/No_Treatment_versus_24_or_60_Weeks_of_Antiretroviral_Treatment_during_Primary_HIV_Infection_The_Randomized_Primo_SHM_Trial/127236", "title"=>"No Treatment versus 24 or 60 Weeks of Antiretroviral Treatment during Primary HIV Infection: The Randomized Primo-SHM Trial", "pos_in_sequence"=>0, "defined_type"=>4, "published_date"=>"2012-03-27 02:00:36"}
  • {"files"=>["https://ndownloader.figshare.com/files/663859"], "description"=>"<p>HBV, hepatitis B virus; LTFU, loss to follow-up.</p>", "links"=>[], "tags"=>["Infectious diseases"], "article_id"=>334337, "categories"=>["Infectious Diseases"], "users"=>["Marlous L. Grijsen", "Radjin Steingrover", "Ferdinand W. N. M. Wit", "Suzanne Jurriaans", "Annelies Verbon", "Kees Brinkman", "Marchina E. van der Ende", "Robin Soetekouw", "Frank de Wolf", "Joep M. A. Lange", "Hanneke Schuitemaker", "Jan M. Prins"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001196.g001", "stats"=>{"downloads"=>1, "page_views"=>7, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_CONSORT_flow_diagram_/334337", "title"=>"CONSORT flow diagram.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2012-03-27 01:12:17"}

PMC Usage Stats | Further Information

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Relative Metric

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