VS411 Reduced Immune Activation and HIV-1 RNA Levels in 28 Days: Randomized Proof-of-Concept Study for AntiViral-HyperActivation Limiting Therapeutics
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{"title"=>"VS411 Reduced Immune Activation and HIV-1 RNA Levels in 28 Days: Randomized Proof-of-Concept Study for AntiViral-HyperActivation Limiting Therapeutics", "type"=>"journal", "authors"=>[{"first_name"=>"Franco", "last_name"=>"Lori", "scopus_author_id"=>"35876579200"}, {"first_name"=>"Davide", "last_name"=>"de Forni", "scopus_author_id"=>"8446425500"}, {"first_name"=>"Elly", "last_name"=>"Katabira", "scopus_author_id"=>"6701499800"}, {"first_name"=>"Denis", "last_name"=>"Baev", "scopus_author_id"=>"24512138100"}, {"first_name"=>"Renato", "last_name"=>"Maserati", "scopus_author_id"=>"7006741051"}, {"first_name"=>"Sandra A.", "last_name"=>"Calarota", "scopus_author_id"=>"6602150689"}, {"first_name"=>"Pedro", "last_name"=>"Cahn", "scopus_author_id"=>"7005552107"}, {"first_name"=>"Marco", "last_name"=>"Testori", "scopus_author_id"=>"55418999200"}, {"first_name"=>"Aza", "last_name"=>"Rakhmanova", "scopus_author_id"=>"34571970700"}, {"first_name"=>"Michael R.", "last_name"=>"Stevens", "scopus_author_id"=>"55435770400"}], "year"=>2012, "source"=>"PLoS ONE", "identifiers"=>{"pui"=>"365883732", "scopus"=>"2-s2.0-84867664994", "pmid"=>"23094055", "doi"=>"10.1371/journal.pone.0047485", "isbn"=>"1932-6203", "issn"=>"19326203", "sgr"=>"84867664994"}, "id"=>"6f07bcd8-0dd3-380f-aecd-9ce2464055c5", "abstract"=>"A new class of antiretrovirals, AntiViral-HyperActivation Limiting Therapeutics (AV-HALTs), has been proposed as a disease-modifying therapy to both reduce Human Immunodeficiency Virus Type 1 (HIV-1) RNA levels and the excessive immune activation now recognized as the major driver of not only the continual loss of CD4(+) T cells and progression to Acquired Immunodeficiency Syndrome (AIDS), but also of the emergence of both AIDS-defining and non-AIDS events that negatively impact upon morbidity and mortality despite successful (ie, fully suppressive) therapy. VS411, the first-in-class AV-HALT, combined low-dose, slow-release didanosine with low-dose hydroxycarbamide to accomplish both objectives with a favorable toxicity profile during short-term administration. Five dose combinations were administered as VS411 to test the AV-HALT Proof-of-Concept in HIV-1-infected subjects.|Multinational, double-blind, 28-day Phase 2a dose-ranging Proof-of-Concept study of antiviral activity, immunological parameters, safety, and genotypic resistance in 58 evaluable antiretroviral-naïve HIV-1-infected adults. Randomization and allocation to study arms were carried out by a central computer system. Results were analyzed by ANOVA, Kruskal-Wallis, ANCOVA, and two-tailed paired t tests.|VS411 was well-tolerated, produced significant reductions of HIV-1 RNA levels, increased CD4(+) T cell counts, and led to significant, rapid, unprecedented reductions of immune activation markers after 28 days despite incomplete viral suppression and without inhibiting HIV-1-specific immune responses. The didanosine 200 mg/HC 900 mg once-daily formulation demonstrated the greatest antiviral efficacy (HIV-1 RNA: -1.47 log(10) copies/mL; CD4(+) T cell count: +135 cells/mm(3)) and fewest adverse events.|VS411 successfully established the Proof-of-Concept that AV-HALTs can combine antiviral efficacy with rapid, potentially beneficial reductions in the excessive immune system activation associated with HIV-1 disease. Rapid reductions in markers of immune system hyperactivation and cellular proliferation were obtained despite the fact that VS411 did not attain maximal suppression of HIV RNA, suggesting this effect was due to the HALT component.|ITEudraCT 2007-002460-98.", "link"=>"http://www.mendeley.com/research/vs411-reduced-immune-activation-hiv1-rna-levels-28-days-randomized-proofofconcept-study-antiviralhyp", "reader_count"=>13, "reader_count_by_academic_status"=>{"Researcher"=>3, "Student > Ph. D. Student"=>4, "Student > Postgraduate"=>1, "Student > Master"=>1, "Other"=>1, "Lecturer > Senior Lecturer"=>1, "Professor"=>1, "Unspecified"=>1}, "reader_count_by_user_role"=>{"Researcher"=>3, "Student > Ph. D. Student"=>4, "Student > Postgraduate"=>1, "Student > Master"=>1, "Other"=>1, "Lecturer > Senior Lecturer"=>1, "Professor"=>1, "Unspecified"=>1}, "reader_count_by_subject_area"=>{"Agricultural and Biological Sciences"=>7, "Medicine and Dentistry"=>2, "Social Sciences"=>2, "Immunology and Microbiology"=>1, "Unspecified"=>1}, "reader_count_by_subdiscipline"=>{"Medicine and Dentistry"=>{"Medicine and Dentistry"=>2}, "Social Sciences"=>{"Social Sciences"=>2}, "Immunology and Microbiology"=>{"Immunology and Microbiology"=>1}, "Agricultural and Biological Sciences"=>{"Agricultural and Biological Sciences"=>7}, "Unspecified"=>{"Unspecified"=>1}}, "reader_count_by_country"=>{"United States"=>1, "South Africa"=>1}, "group_count"=>0}

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Figshare

  • {"files"=>["https://ndownloader.figshare.com/files/555858"], "description"=>"a<p>ddI  =  didanosine.</p>b<p>EC  =  Enterically coated.</p>c<p>HC  =  hydroxycarbamide.</p>", "links"=>[], "tags"=>["vs411"], "article_id"=>226349, "categories"=>["Pharmacology", "Virology", "Infectious Diseases", "Immunology"], "users"=>["Franco Lori", "Davide De Forni", "Elly Katabira", "Denis Baev", "Renato Maserati", "Sandra A. Calarota", "Pedro Cahn", "Marco Testori", "Aza Rakhmanova", "Michael R. Stevens"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0047485.t002", "stats"=>{"downloads"=>0, "page_views"=>33, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Components_of_the_VS411_capsules_/226349", "title"=>"Components of the VS411 capsules.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2012-10-19 01:45:49"}
  • {"files"=>["https://ndownloader.figshare.com/files/555382"], "description"=>"<p>Statistically significant (<i>P</i><.001) HIV-1 RNA reductions were seen in each of the five VS411 dose arms with a median reduction in HIV-1 RNA across combined study arms at Day 29 of −1.47 log<sub>10</sub>. There was a trend toward greater reductions with increasing doses of both didanosine and hydroxycarbamide. Only two of 58 evaluable subjects (3%) achieved HIV-1 RNA reductions to <50 copies/mL by Day 29.</p>", "links"=>[], "tags"=>["rna", "median"], "article_id"=>225868, "categories"=>["Pharmacology", "Virology", "Infectious Diseases", "Immunology"], "users"=>["Franco Lori", "Davide De Forni", "Elly Katabira", "Denis Baev", "Renato Maserati", "Sandra A. Calarota", "Pedro Cahn", "Marco Testori", "Aza Rakhmanova", "Michael R. Stevens"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0047485.g002", "stats"=>{"downloads"=>1, "page_views"=>19, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_HIV_1_RNA_log_10_copies_mL_median_change_from_Day_1_to_Day_29_/225868", "title"=>"HIV-1 RNA (log<sub>10</sub> copies/mL) median change from Day 1 to Day 29.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2012-10-19 01:37:48"}
  • {"files"=>["https://ndownloader.figshare.com/files/555987"], "description"=>"a<p>SOC  =  System Organ Class.</p>b<p>ddI  =  didanosine.</p>c<p>HC  =  hydroxycarbamide.</p>d<p>modified ITT population.</p>", "links"=>[], "tags"=>["adverse", "events"], "article_id"=>226472, "categories"=>["Pharmacology", "Virology", "Infectious Diseases", "Immunology"], "users"=>["Franco Lori", "Davide De Forni", "Elly Katabira", "Denis Baev", "Renato Maserati", "Sandra A. Calarota", "Pedro Cahn", "Marco Testori", "Aza Rakhmanova", "Michael R. Stevens"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0047485.t005", "stats"=>{"downloads"=>1, "page_views"=>11, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Subjects_with_adverse_events_AEs_by_system_organ_class_and_treatment_group_/226472", "title"=>"Subjects with adverse events (AEs) by system organ class and treatment group.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2012-10-19 01:47:52"}
  • {"files"=>["https://ndownloader.figshare.com/files/555942"], "description"=>"a<p>ddI  =  didanosine.</p>b<p>HC  =  hydroxycarbamide.</p>c<p>modified ITT population.</p>d<p>BMI  =  Body Mass Index.</p>", "links"=>[], "tags"=>["Virology", "immunology", "Infectious diseases", "pharmacology"], "article_id"=>226421, "categories"=>["Pharmacology", "Virology", "Infectious Diseases", "Immunology"], "users"=>["Franco Lori", "Davide De Forni", "Elly Katabira", "Denis Baev", "Renato Maserati", "Sandra A. Calarota", "Pedro Cahn", "Marco Testori", "Aza Rakhmanova", "Michael R. Stevens"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0047485.t004", "stats"=>{"downloads"=>0, "page_views"=>4, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Baseline_characteristics_/226421", "title"=>"Baseline characteristics.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2012-10-19 01:47:01"}
  • {"files"=>["https://ndownloader.figshare.com/files/555295"], "description"=>"<p>CONSORT Flow Diagram.</p>", "links"=>[], "tags"=>["Virology", "immunology", "Infectious diseases", "pharmacology"], "article_id"=>225780, "categories"=>["Pharmacology", "Virology", "Infectious Diseases", "Immunology"], "users"=>["Franco Lori", "Davide De Forni", "Elly Katabira", "Denis Baev", "Renato Maserati", "Sandra A. Calarota", "Pedro Cahn", "Marco Testori", "Aza Rakhmanova", "Michael R. Stevens"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0047485.g001", "stats"=>{"downloads"=>1, "page_views"=>10, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_CONSORT_Flow_Diagram_/225780", "title"=>"CONSORT Flow Diagram.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2012-10-19 01:36:20"}
  • {"files"=>["https://ndownloader.figshare.com/files/555898"], "description"=>"a<p>ddI  =  didanosine.</p>b<p>HC  =  hydroxycarbamide.</p>", "links"=>[], "tags"=>["vs411", "capsules"], "article_id"=>226382, "categories"=>["Pharmacology", "Virology", "Infectious Diseases", "Immunology"], "users"=>["Franco Lori", "Davide De Forni", "Elly Katabira", "Denis Baev", "Renato Maserati", "Sandra A. Calarota", "Pedro Cahn", "Marco Testori", "Aza Rakhmanova", "Michael R. Stevens"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0047485.t003", "stats"=>{"downloads"=>1, "page_views"=>39, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Number_of_VS411_capsules_required_for_each_study_arm_/226382", "title"=>"Number of VS411 capsules required for each study arm.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2012-10-19 01:46:22"}
  • {"files"=>["https://ndownloader.figshare.com/files/555733"], "description"=>"<p>A sub-study of 22 individuals was conducted to evaluate whether VS411 induced an immunosuppressive effect on T lymphocytes. IFN-<b>γ</b> responses specific for Gag (A) and for Rev/Tat (B) and dual IFN-<b>γ</b>/IL-2 responses specific for Gag (C) and for Rev/Tat (D) at baseline and after 28 days treatment (Day 29) were measured by ELIPSOT (spots/million PBMCs). Horizontal red lines indicate mean values. There were no significant differences seen between pre- and post-therapy analyses suggesting that VS411 had no immunosuppressive effect on HIV-1-specific immune responses.</p>", "links"=>[], "tags"=>["dual", "elipsot", "baseline"], "article_id"=>226218, "categories"=>["Pharmacology", "Virology", "Infectious Diseases", "Immunology"], "users"=>["Franco Lori", "Davide De Forni", "Elly Katabira", "Denis Baev", "Renato Maserati", "Sandra A. Calarota", "Pedro Cahn", "Marco Testori", "Aza Rakhmanova", "Michael R. Stevens"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0047485.g005", "stats"=>{"downloads"=>2, "page_views"=>9, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_IFN_947_and_dual_IFN_947_IL_2_measured_by_ELIPSOT_at_Baseline_and_Day_29_/226218", "title"=>"IFN-γ and dual IFN-γ/IL-2 measured by ELIPSOT at Baseline and Day 29.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2012-10-19 01:43:38"}
  • {"files"=>["https://ndownloader.figshare.com/files/555488"], "description"=>"<p>The median change in CD4<sup>+</sup> T cell count for the combined study arms after 28 days of treatment was +53 cells/mm<sup>3</sup> in the mITT analysis (<i>P</i><.002). There was a trend toward a dose-response relationship seen for HC in both the half-dose and the full-dose didanosine arms.</p>", "links"=>[], "tags"=>["median"], "article_id"=>225974, "categories"=>["Pharmacology", "Virology", "Infectious Diseases", "Immunology"], "users"=>["Franco Lori", "Davide De Forni", "Elly Katabira", "Denis Baev", "Renato Maserati", "Sandra A. Calarota", "Pedro Cahn", "Marco Testori", "Aza Rakhmanova", "Michael R. Stevens"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0047485.g003", "stats"=>{"downloads"=>1, "page_views"=>5, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_CD4_T_cell_count_cells_mm_3_median_change_from_Day_1_to_Day_29_/225974", "title"=>"CD4<sup>+</sup> T cell count (cells/mm<sup>3</sup>) median change from Day 1 to Day 29.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2012-10-19 01:39:34"}
  • {"files"=>["https://ndownloader.figshare.com/files/555645"], "description"=>"<p>In a sub-study of 32 of the 56 subjects completing VS411 for 28 days, rapid and statistically significant reductions were seen in the percentage of CD4<sup>+</sup> (A) and CD8<sup>+</sup> (B) cells co-expressing the two markers of cellular activation, CD38 and HLA-DR. After 28 days of VS411 treatment, the median percentage of CD4<sup>+</sup> and CD8<sup>+</sup> T cells co-expressing the two markers (C) decreased by 28.9% (from 6.09% to 4.33%) and 34.4% (from 25.87% to 16.98%), respectively (<i>P</i><.005). These statistically significant reductions were obtained despite the fact that VS411 did not attain maximal suppression of HIV-1 RNA, suggesting the effect was due to the HALT component of this AV-HALT combination. In (A) and (B) the grey boxes span the 25<sup>th</sup> and 75<sup>th</sup> percentile values. The error bars span the 10<sup>th</sup> and the 90<sup>th</sup> percentile values. Each midline represents the median value. The dots represent individual observations below the 10<sup>th</sup> and above 90<sup>th</sup> percentile values.</p>", "links"=>[], "tags"=>["cells", "co-expressing", "hla-dr"], "article_id"=>226131, "categories"=>["Pharmacology", "Virology", "Infectious Diseases", "Immunology"], "users"=>["Franco Lori", "Davide De Forni", "Elly Katabira", "Denis Baev", "Renato Maserati", "Sandra A. Calarota", "Pedro Cahn", "Marco Testori", "Aza Rakhmanova", "Michael R. Stevens"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0047485.g004", "stats"=>{"downloads"=>1, "page_views"=>6, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_CD4_and_CD8_T_cells_co_expressing_HLA_DR_and_CD38_/226131", "title"=>"CD4<sup>+</sup> and CD8<sup>+</sup> T cells co-expressing HLA-DR and CD38.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2012-10-19 01:42:11"}
  • {"files"=>["https://ndownloader.figshare.com/files/555822"], "description"=>"a<p>A maximum of 35 randomized subjects was set for Uganda.</p>", "links"=>[], "tags"=>["Virology", "immunology", "Infectious diseases", "pharmacology"], "article_id"=>226308, "categories"=>["Pharmacology", "Virology", "Infectious Diseases", "Immunology"], "users"=>["Franco Lori", "Davide De Forni", "Elly Katabira", "Denis Baev", "Renato Maserati", "Sandra A. Calarota", "Pedro Cahn", "Marco Testori", "Aza Rakhmanova", "Michael R. Stevens"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0047485.t001", "stats"=>{"downloads"=>1, "page_views"=>5, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Distribution_of_medication_8220_block_wise_8221_to_the_study_counties_/226308", "title"=>"Distribution of medication “block-wise” to the study counties.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2012-10-19 01:45:08"}
  • {"files"=>["https://ndownloader.figshare.com/files/296905", "https://ndownloader.figshare.com/files/296972", "https://ndownloader.figshare.com/files/297149"], "description"=>"<div><h3>Background</h3><p>A new class of antiretrovirals, AntiViral-HyperActivation Limiting Therapeutics (AV-HALTs), has been proposed as a disease-modifying therapy to both reduce Human Immunodeficiency Virus Type 1 (HIV-1) RNA levels and the excessive immune activation now recognized as the major driver of not only the continual loss of CD4<sup>+</sup> T cells and progression to Acquired Immunodeficiency Syndrome (AIDS), but also of the emergence of both AIDS-defining and non-AIDS events that negatively impact upon morbidity and mortality despite successful (<em>ie, fully suppressive</em>) therapy. VS411, the first-in-class AV-HALT, combined low-dose, slow-release didanosine with low-dose hydroxycarbamide to accomplish both objectives with a favorable toxicity profile during short-term administration. Five dose combinations were administered as VS411 to test the AV-HALT Proof-of-Concept in HIV-1-infected subjects.</p> <h3>Methods</h3><p>Multinational, double-blind, 28-day Phase 2a dose-ranging Proof-of-Concept study of antiviral activity, immunological parameters, safety, and genotypic resistance in 58 evaluable antiretroviral-naïve HIV-1-infected adults. Randomization and allocation to study arms were carried out by a central computer system. Results were analyzed by ANOVA, Kruskal-Wallis, ANCOVA, and two-tailed paired <em>t</em> tests.</p> <h3>Results</h3><p>VS411 was well-tolerated, produced significant reductions of HIV-1 RNA levels, increased CD4<sup>+</sup> T cell counts, and led to significant, rapid, unprecedented reductions of immune activation markers after 28 days despite incomplete viral suppression and without inhibiting HIV-1-specific immune responses. The didanosine 200 mg/HC 900 mg once-daily formulation demonstrated the greatest antiviral efficacy (HIV-1 RNA: −1.47 log<sub>10</sub> copies/mL; CD4<sup>+</sup> T cell count: +135 cells/mm<sup>3</sup>) and fewest adverse events.</p> <h3>Conclusions</h3><p>VS411 successfully established the Proof-of-Concept that AV-HALTs can combine antiviral efficacy with rapid, potentially beneficial reductions in the excessive immune system activation associated with HIV-1 disease. Rapid reductions in markers of immune system hyperactivation and cellular proliferation were obtained despite the fact that VS411 did not attain maximal suppression of HIV RNA, suggesting this effect was due to the HALT component.</p> <h3>Trial Registration</h3><p>ITEudraCT 2007-002460-98</p> </div>", "links"=>[], "tags"=>["vs411", "reduced", "activation", "hiv-1", "rna", "levels", "28", "randomized", "proof-of-concept", "antiviral-hyperactivation", "limiting", "therapeutics"], "article_id"=>118497, "categories"=>["Cancer", "Pharmacology", "Immunology"], "users"=>["Franco Lori", "Davide De Forni", "Elly Katabira", "Denis Baev", "Renato Maserati", "Sandra A. Calarota", "Pedro Cahn", "Marco Testori", "Aza Rakhmanova", "Michael R. Stevens"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0047485.s001", "https://dx.doi.org/10.1371/journal.pone.0047485.s002", "https://dx.doi.org/10.1371/journal.pone.0047485.s003"], "stats"=>{"downloads"=>12, "page_views"=>12, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/VS411_Reduced_Immune_Activation_and_HIV_1_RNA_Levels_in_28_Days_Randomized_Proof_of_Concept_Study_for_AntiViral_HyperActivation_Limiting_Therapeutics/118497", "title"=>"VS411 Reduced Immune Activation and HIV-1 RNA Levels in 28 Days: Randomized Proof-of-Concept Study for AntiViral-HyperActivation Limiting Therapeutics", "pos_in_sequence"=>0, "defined_type"=>4, "published_date"=>"2012-10-19 02:21:37"}
  • {"files"=>["https://ndownloader.figshare.com/files/556031"], "description"=>"a<p>SD  =  Standard Deviation.</p>", "links"=>[], "tags"=>["markers", "activation", "28", "days"], "article_id"=>226514, "categories"=>["Pharmacology", "Virology", "Infectious Diseases", "Immunology"], "users"=>["Franco Lori", "Davide De Forni", "Elly Katabira", "Denis Baev", "Renato Maserati", "Sandra A. Calarota", "Pedro Cahn", "Marco Testori", "Aza Rakhmanova", "Michael R. Stevens"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0047485.t006", "stats"=>{"downloads"=>0, "page_views"=>4, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Changes_in_markers_of_excessive_immune_system_activation_after_28_days_of_treatment_with_VS411_/226514", "title"=>"Changes in markers of excessive immune system activation after 28 days of treatment with VS411.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2012-10-19 01:48:34"}

PMC Usage Stats | Further Information

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Relative Metric

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