Effects of Intermittent IL-2 Alone or with Peri-Cycle Antiretroviral Therapy in Early HIV Infection: The STALWART Study
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"last_name"=>"Portsmouth", "scopus_author_id"=>"6701632013"}, {"first_name"=>"Alan", "last_name"=>"Winston", "scopus_author_id"=>"9241624100"}, {"first_name"=>"Martin J.", "last_name"=>"Wiselka", "scopus_author_id"=>"7004831677"}, {"first_name"=>"Gregory M.", "last_name"=>"Anstead", "scopus_author_id"=>"6701765933"}, {"first_name"=>"Roberto C.", "last_name"=>"Arduino", "scopus_author_id"=>"6701800326"}, {"first_name"=>"Matthew B.", "last_name"=>"Goetz", "scopus_author_id"=>"7101881552"}, {"first_name"=>"Karen", "last_name"=>"Hennessey", "scopus_author_id"=>"57197346797"}, {"first_name"=>"Wafaa", "last_name"=>"El-Sadr", "scopus_author_id"=>"56751023900"}, {"first_name"=>"Ann M.", "last_name"=>"Labriola", "scopus_author_id"=>"6701774754"}, {"first_name"=>"Daniel E.", "last_name"=>"Nixon", "scopus_author_id"=>"15045394100"}, {"first_name"=>"Maria C.", "last_name"=>"Rodriguez-Barradas", "scopus_author_id"=>"7004239612"}], "year"=>2010, "source"=>"PLoS ONE", "identifiers"=>{"doi"=>"10.1371/journal.pone.0009334", "sgr"=>"77949618628", "issn"=>"19326203", "pui"=>"358487252", "isbn"=>"1932-6203 (Electronic)\\n1932-6203 (Linking)", "pmid"=>"20186278", "scopus"=>"2-s2.0-77949618628"}, "id"=>"cb049d93-31ad-3bca-9b6c-c04399bacd8a", "abstract"=>"Background: The Study of Aldesleukin with and without antiretroviral therapy (STALWART) evaluated whether intermittent interleukin-2 (IL-2) alone or with antiretroviral therapy (ART) around IL-2 cycles increased CD4+ counts compared to no therapy. Methodology: Participants not on continuous ART with 300 CD4+ cells/mm3 were randomized to: no treatment; IL-2 for 5 consecutive days every 8 weeks for 3 cycles; or the same IL-2 regimen with 10 days of ART administered around each IL-2 cycle. CD4+ counts, HIV RNA, and HIV progression events were collected monthly. Principal Findings: A total of 267 participants were randomized. At week 32, the mean CD4+ count was 134 cells greater in the IL-2 alone group (p<0.001), and 133 cells greater in the IL-2 plus ART group (p<0.001) compared to the no therapy group. Twelve participants in the IL-2 groups compared to 1 participant in the group assigned to no therapy experienced an opportunistic event or died (HR 5.84, CI: 0.59 to 43.57; p=0.009). Conclusions: IL-2 alone or with peri-cycle HAART increases CD4+ counts but was associated with a greater number of opportunistic events or deaths compared to no therapy. These results call into question the immunoprotective significance of IL-2-induced CD4+ cells. Trial Registration: ClinicalTrials.gov NCT00110812", "link"=>"http://www.mendeley.com/research/effects-intermittent-il2-alone-pericycle-antiretroviral-therapy-early-hiv-infection-stalwart-study", "reader_count"=>28, "reader_count_by_academic_status"=>{"Unspecified"=>2, "Professor > Associate Professor"=>2, "Researcher"=>6, "Student > Doctoral Student"=>1, "Student > Ph. D. Student"=>5, "Other"=>6, "Student > Master"=>1, "Student > Bachelor"=>2, "Professor"=>3}, "reader_count_by_user_role"=>{"Unspecified"=>2, "Professor > Associate Professor"=>2, "Researcher"=>6, "Student > Doctoral Student"=>1, "Student > Ph. D. Student"=>5, "Other"=>6, "Student > Master"=>1, "Student > Bachelor"=>2, "Professor"=>3}, "reader_count_by_subject_area"=>{"Unspecified"=>5, "Biochemistry, Genetics and Molecular Biology"=>1, "Nursing and Health Professions"=>1, "Medicine and Dentistry"=>9, "Agricultural and Biological Sciences"=>4, "Pharmacology, Toxicology and Pharmaceutical Science"=>1, "Social Sciences"=>4, "Computer Science"=>1, "Immunology and Microbiology"=>1, "Neuroscience"=>1}, "reader_count_by_subdiscipline"=>{"Medicine and Dentistry"=>{"Medicine and Dentistry"=>9}, "Neuroscience"=>{"Neuroscience"=>1}, "Social Sciences"=>{"Social Sciences"=>4}, "Immunology and Microbiology"=>{"Immunology and Microbiology"=>1}, "Agricultural and Biological Sciences"=>{"Agricultural and Biological Sciences"=>4}, "Computer Science"=>{"Computer Science"=>1}, "Nursing and Health Professions"=>{"Nursing and Health Professions"=>1}, "Biochemistry, Genetics and Molecular Biology"=>{"Biochemistry, Genetics and Molecular Biology"=>1}, "Unspecified"=>{"Unspecified"=>5}, "Pharmacology, Toxicology and Pharmaceutical Science"=>{"Pharmacology, Toxicology and Pharmaceutical Science"=>1}}, "group_count"=>0}

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  • {"month"=>"7", "year"=>"2015", "pdf_views"=>"0", "xml_views"=>"0", "html_views"=>"32"}
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Figshare

  • {"files"=>["https://ndownloader.figshare.com/files/862109"], "description"=>"<p>Median CD4+ cell count.</p>", "links"=>[], "tags"=>["immunology", "Infectious diseases", "immunology/immunomodulation", "infectious diseases/hiv infection and aids", "infectious diseases/viral infections"], "article_id"=>532565, "categories"=>["Infectious Diseases", "Medicine", "Immunology"], "users"=>["Jorge A. Tavel"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0009334.g002", "stats"=>{"downloads"=>0, "page_views"=>1, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Median_CD4_cell_count_/532565", "title"=>"Median CD4+ cell count.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2010-02-23 00:42:45"}
  • {"files"=>["https://ndownloader.figshare.com/files/862013"], "description"=>"<p>STALWART study design and CONSORT flow diagram.</p>", "links"=>[], "tags"=>["consort"], "article_id"=>532470, "categories"=>["Infectious Diseases", "Medicine", "Immunology"], "users"=>["Jorge A. Tavel"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0009334.g001", "stats"=>{"downloads"=>1, "page_views"=>4, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_STALWART_study_design_and_CONSORT_flow_diagram_/532470", "title"=>"STALWART study design and CONSORT flow diagram.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2010-02-23 00:41:10"}
  • {"files"=>["https://ndownloader.figshare.com/files/862298"], "description"=>"<p>Reported disease progression events.</p>", "links"=>[], "tags"=>["progression"], "article_id"=>532759, "categories"=>["Infectious Diseases", "Medicine", "Immunology"], "users"=>["Jorge A. Tavel"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0009334.t002", "stats"=>{"downloads"=>0, "page_views"=>4, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Reported_disease_progression_events_/532759", "title"=>"Reported disease progression events.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2010-02-23 00:45:59"}
  • {"files"=>["https://ndownloader.figshare.com/files/862332"], "description"=>"<p>*among antiretroviral experienced patients.</p><p>**more than one could be checked.</p>", "links"=>[], "tags"=>["characteristics"], "article_id"=>532792, "categories"=>["Infectious Diseases", "Medicine", "Immunology"], "users"=>["Jorge A. Tavel"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0009334.t001", "stats"=>{"downloads"=>1, "page_views"=>3, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Baseline_characteristics_by_treatment_group_/532792", "title"=>"Baseline characteristics by treatment group.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2010-02-23 00:46:32"}
  • {"files"=>["https://ndownloader.figshare.com/files/862173"], "description"=>"<p>Time to first use of continuous antiretroviral therapy and time to first opportunistic event or death.</p>", "links"=>[], "tags"=>["antiretroviral", "opportunistic"], "article_id"=>532634, "categories"=>["Infectious Diseases", "Medicine", "Immunology"], "users"=>["Jorge A. Tavel"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0009334.g003", "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Time_to_first_use_of_continuous_antiretroviral_therapy_and_time_to_first_opportunistic_event_or_death_/532634", "title"=>"Time to first use of continuous antiretroviral therapy and time to first opportunistic event or death.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2010-02-23 00:43:54"}
  • {"files"=>["https://ndownloader.figshare.com/files/427904", "https://ndownloader.figshare.com/files/428038"], "description"=>"<div><h3>Background</h3><p>The <b>St</b>udy of <b>Al</b>desleukin <b>w</b>ith and without <b>a</b>nti<b>r</b>etroviral <b>t</b>herapy (STALWART) evaluated whether intermittent interleukin-2 (IL-2) alone or with antiretroviral therapy (ART) around IL-2 cycles increased CD4<sup>+</sup> counts compared to no therapy.</p><h3>Methodology</h3><p>Participants not on continuous ART with ≥300 CD4<sup>+</sup> cells/mm<sup>3</sup> were randomized to: no treatment; IL-2 for 5 consecutive days every 8 weeks for 3 cycles; or the same IL-2 regimen with 10 days of ART administered around each IL-2 cycle. CD4<sup>+</sup> counts, HIV RNA, and HIV progression events were collected monthly.</p><h3>Principal Findings</h3><p>A total of 267 participants were randomized. At week 32, the mean CD4<sup>+</sup> count was 134 cells greater in the IL-2 alone group (p<0.001), and 133 cells greater in the IL-2 plus ART group (p<0.001) compared to the no therapy group. Twelve participants in the IL-2 groups compared to 1 participant in the group assigned to no therapy experienced an opportunistic event or died (HR 5.84, CI: 0.59 to 43.57; p = 0.009).</p><h3>Conclusions</h3><p>IL-2 alone or with peri-cycle HAART increases CD4<sup>+</sup> counts but was associated with a greater number of opportunistic events or deaths compared to no therapy. These results call into question the immunoprotective significance of IL-2-induced CD4<sup>+</sup> cells.</p><h3>Trial Registration</h3><p>ClinicalTrials.gov <a href=\"http://clinicaltrials.gov/ct2/show/NCT00110812\">NCT00110812</a></p></div>", "links"=>[], "tags"=>["effects", "intermittent", "il-2", "peri-cycle", "antiretroviral", "hiv", "stalwart"], "article_id"=>144493, "categories"=>["Cancer", "Medicine", "Immunology"], "users"=>["Jorge A. Tavel"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0009334.s001", "https://dx.doi.org/10.1371/journal.pone.0009334.s002"], "stats"=>{"downloads"=>7, "page_views"=>11, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/Effects_of_Intermittent_IL_2_Alone_or_with_Peri_Cycle_Antiretroviral_Therapy_in_Early_HIV_Infection_The_STALWART_Study/144493", "title"=>"Effects of Intermittent IL-2 Alone or with Peri-Cycle Antiretroviral Therapy in Early HIV Infection: The STALWART Study", "pos_in_sequence"=>0, "defined_type"=>4, "published_date"=>"2010-02-23 01:14:53"}

PMC Usage Stats | Further Information

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  • {"unique-ip"=>"11", "full-text"=>"10", "pdf"=>"2", "abstract"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2016", "month"=>"10"}
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  • {"unique-ip"=>"13", "full-text"=>"13", "pdf"=>"1", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2018", "month"=>"10"}
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  • {"unique-ip"=>"5", "full-text"=>"5", "pdf"=>"1", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"1", "year"=>"2018", "month"=>"8"}
  • {"unique-ip"=>"14", "full-text"=>"11", "pdf"=>"3", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"2", "cited-by"=>"1", "year"=>"2018", "month"=>"11"}
  • {"unique-ip"=>"14", "full-text"=>"15", "pdf"=>"1", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"1", "year"=>"2018", "month"=>"9"}
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  • {"unique-ip"=>"9", "full-text"=>"10", "pdf"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"2", "cited-by"=>"1", "year"=>"2019", "month"=>"3"}
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Relative Metric

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