A Randomized, Controlled, Trial of Short Cycle Intermittent Compared to Continuous Antiretroviral Therapy for the Treatment of HIV Infection in Uganda
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Mendeley | Further Information

{"title"=>"A Randomized, Controlled, Trial of Short Cycle Intermittent Compared to Continuous Antiretroviral Therapy for the Treatment of HIV Infection in Uganda", "type"=>"journal", "authors"=>[{"first_name"=>"Steven J.", "last_name"=>"Reynolds"}, {"first_name"=>"Cissy", "last_name"=>"Kityo"}, {"first_name"=>"Claire W.", "last_name"=>"Hallahan"}, {"first_name"=>"Geoffrey", "last_name"=>"Kabuye"}, {"first_name"=>"Diana", "last_name"=>"Atwiine"}, {"first_name"=>"Frank", "last_name"=>"Mbamanya"}, {"first_name"=>"Francis", "last_name"=>"Ssali"}, {"first_name"=>"Robin", "last_name"=>"Dewar"}, {"first_name"=>"Marybeth", "last_name"=>"Daucher"}, {"first_name"=>"Richard T.", "last_name"=>"Davey"}, {"first_name"=>"Peter", "last_name"=>"Mugyenyi"}, {"first_name"=>"Anthony S.", "last_name"=>"Fauci"}, {"first_name"=>"Thomas C.", "last_name"=>"Quinn"}, {"first_name"=>"Mark R.", "last_name"=>"Dybul"}], "year"=>2010, "source"=>"PLoS ONE", "identifiers"=>{"pui"=>"359494237", "sgr"=>"77956405792", "issn"=>"1932-6203", "pmid"=>"20442758", "scopus"=>"2-s2.0-77956405792", "doi"=>"10.1371/journal.pone.0010307", "isbn"=>"1932-6203 (Electronic)\\r1932-6203 (Linking)"}, "id"=>"2d2b8117-ca5e-3e47-8d11-24b4846e205d", "abstract"=>"BACKGROUND: Short cycle treatment interruption could reduce toxicity and drug costs and contribute to further expansion of antiretroviral therapy (ART) programs. METHODS: A 72 week, non-inferiority trial enrolled one hundred forty six HIV positive persons receiving ART (CD4+ cell count > or =125 cells/mm(3) and HIV RNA plasma levels <50 copies/ml) in one of three arms: continuous, 7 days on/7 days off and 5 days on/2 days off treatment. Primary endpoint was ART treatment failure determined by plasma HIV RNA level, CD4+ cell count decrease, death attributed to study participation, or opportunistic infection. RESULTS: Following enrollment of 32 participants, the 7 days on/7 days off arm was closed because of a failure rate of 31%. Six of 52 (11.5%) participants in the 5 days on/2 days off arm failed. Five had virologic failure and one participant had immunologic failure. Eleven of 51 (21.6%) participants in the continuous treatment arm failed. Nine had virologic failure with 1 death (lactic acidosis) and 1 clinical failure (extra-pulmonary TB). The upper 97.5% confidence boundary for the difference between the percent of non-failures in the 5 days on/2 days off arm (88.5% non-failure) compared to continuous treatment (78.4% non failure) was 4.8% which is well within the preset non-inferiority margin of 15%. No significant difference was found in time to failure in the 2 study arms (p = 0.39). CONCLUSIONS: Short cycle 5 days on/2 days off intermittent ART was at least as effective as continuous therapy. TRIAL REGISTRATION: ClinicalTrials.gov NCT00339456.", "link"=>"http://www.mendeley.com/research/randomized-controlled-trial-short-cycle-intermittent-compared-continuous-antiretroviral-therapy-trea", "reader_count"=>27, "reader_count_by_academic_status"=>{"Unspecified"=>1, "Professor > Associate Professor"=>2, "Researcher"=>9, "Student > Ph. D. Student"=>4, "Student > Postgraduate"=>1, "Student > Master"=>3, "Other"=>2, "Student > Bachelor"=>1, "Lecturer"=>2, "Lecturer > Senior Lecturer"=>1, "Student > Doctoral Student"=>1}, "reader_count_by_user_role"=>{"Unspecified"=>1, "Professor > Associate Professor"=>2, "Researcher"=>9, "Student > Ph. D. Student"=>4, "Student > Postgraduate"=>1, "Student > Master"=>3, "Other"=>2, "Student > Bachelor"=>1, "Lecturer"=>2, "Lecturer > Senior Lecturer"=>1, "Student > Doctoral Student"=>1}, "reader_count_by_subject_area"=>{"Unspecified"=>4, "Nursing and Health Professions"=>2, "Mathematics"=>1, "Medicine and Dentistry"=>11, "Agricultural and Biological Sciences"=>4, "Arts and Humanities"=>1, "Social Sciences"=>1, "Computer Science"=>1, "Economics, Econometrics and Finance"=>2}, "reader_count_by_subdiscipline"=>{"Medicine and Dentistry"=>{"Medicine and Dentistry"=>11}, "Social Sciences"=>{"Social Sciences"=>1}, "Economics, Econometrics and Finance"=>{"Economics, Econometrics and Finance"=>2}, "Agricultural and Biological Sciences"=>{"Agricultural and Biological Sciences"=>4}, "Computer Science"=>{"Computer Science"=>1}, "Nursing and Health Professions"=>{"Nursing and Health Professions"=>2}, "Mathematics"=>{"Mathematics"=>1}, "Unspecified"=>{"Unspecified"=>4}, "Arts and Humanities"=>{"Arts and Humanities"=>1}}, "reader_count_by_country"=>{"United Kingdom"=>1, "Ethiopia"=>1}, "group_count"=>4}

Scopus | Further Information

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  • {"files"=>["https://ndownloader.figshare.com/files/424071", "https://ndownloader.figshare.com/files/424210"], "description"=>"<div><h3>Background</h3><p>Short cycle treatment interruption could reduce toxicity and drug costs and contribute to further expansion of antiretroviral therapy (ART) programs.</p><h3>Methods</h3><p>A 72 week, non-inferiority trial enrolled one hundred forty six HIV positive persons receiving ART (CD4+ cell count ≥125 cells/mm<sup>3</sup> and HIV RNA plasma levels <50 copies/ml) in one of three arms: continuous, 7 days on/7 days off and 5 days on/2 days off treatment. Primary endpoint was ART treatment failure determined by plasma HIV RNA level, CD4+ cell count decrease, death attributed to study participation, or opportunistic infection.</p><h3>Results</h3><p>Following enrollment of 32 participants, the 7 days on/7 days off arm was closed because of a failure rate of 31%. Six of 52 (11.5%) participants in the 5 days on/2 days off arm failed. Five had virologic failure and one participant had immunologic failure. Eleven of 51 (21.6%) participants in the continuous treatment arm failed. Nine had virologic failure with 1 death (lactic acidosis) and 1 clinical failure (extra-pulmonary TB). The upper 97.5% confidence boundary for the difference between the percent of non-failures in the 5 days on/2 days off arm (88.5% non-failure) compared to continuous treatment (78.4% non failure) was 4.8% which is well within the preset non-inferiority margin of 15%. No significant difference was found in time to failure in the 2 study arms (p = 0.39).</p><h3>Conclusions</h3><p>Short cycle 5 days on/2 days off intermittent ART was at least as effective as continuous therapy.</p><h3>Trial Registration</h3><p>ClinicalTrials.gov <a href=\"http://www.clinicaltrials.gov/ct2/show/NCT00339456\">NCT00339456</a></p></div>", "links"=>[], "tags"=>["intermittent", "compared", "antiretroviral", "hiv", "uganda"], "article_id"=>143725, "categories"=>["Cancer", "Medicine"], "users"=>["Steven J. Reynolds", "Cissy Kityo", "Claire W. Hallahan", "Geoffrey Kabuye", "Diana Atwiine", "Frank Mbamanya", "Francis Ssali", "Robin Dewar", "Marybeth Daucher", "Richard T. Davey Jr", "Peter Mugyenyi", "Anthony S. Fauci", "Thomas C. Quinn", "Mark R. Dybul"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0010307.s001", "https://dx.doi.org/10.1371/journal.pone.0010307.s002"], "stats"=>{"downloads"=>5, "page_views"=>10, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/A_Randomized_Controlled_Trial_of_Short_Cycle_Intermittent_Compared_to_Continuous_Antiretroviral_Therapy_for_the_Treatment_of_HIV_Infection_in_Uganda/143725", "title"=>"A Randomized, Controlled, Trial of Short Cycle Intermittent Compared to Continuous Antiretroviral Therapy for the Treatment of HIV Infection in Uganda", "pos_in_sequence"=>0, "defined_type"=>4, "published_date"=>"2010-04-22 01:02:05"}
  • {"files"=>["https://ndownloader.figshare.com/files/852723"], "description"=>"<p>Flow diagram for study eligibility and follow-up.</p>", "links"=>[], "tags"=>["diagram", "eligibility"], "article_id"=>523166, "categories"=>["Infectious Diseases", "Medicine", "Cancer"], "users"=>["Steven J. Reynolds", "Cissy Kityo", "Claire W. Hallahan", "Geoffrey Kabuye", "Diana Atwiine", "Frank Mbamanya", "Francis Ssali", "Robin Dewar", "Marybeth Daucher", "Richard T. Davey Jr", "Peter Mugyenyi", "Anthony S. Fauci", "Thomas C. Quinn", "Mark R. Dybul"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0010307.g001", "stats"=>{"downloads"=>0, "page_views"=>5, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Flow_diagram_for_study_eligibility_and_follow_up_/523166", "title"=>"Flow diagram for study eligibility and follow-up.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2010-04-22 00:52:46"}
  • {"files"=>["https://ndownloader.figshare.com/files/853113"], "description"=>"#<p>n = 55 in Continuous arm.</p><p>*Median (IQR).</p><p>**The 7 days on and 7 days off arm was closed following enrollment of 32 participants because of a 31% failure rate in this group found during interim analysis.</p>", "links"=>[], "tags"=>["infectious diseases/hiv infection and aids", "infectious diseases/viral infections", "public health and epidemiology/global health"], "article_id"=>523560, "categories"=>["Infectious Diseases", "Medicine", "Cancer"], "users"=>["Steven J. Reynolds", "Cissy Kityo", "Claire W. Hallahan", "Geoffrey Kabuye", "Diana Atwiine", "Frank Mbamanya", "Francis Ssali", "Robin Dewar", "Marybeth Daucher", "Richard T. Davey Jr", "Peter Mugyenyi", "Anthony S. Fauci", "Thomas C. Quinn", "Mark R. Dybul"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0010307.t001", "stats"=>{"downloads"=>0, "page_views"=>5, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Baseline_Characteristics_/523560", "title"=>"Baseline Characteristics.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2010-04-22 00:59:20"}
  • {"files"=>["https://ndownloader.figshare.com/files/853075"], "description"=>"<p>*stavudine patient years, subanalysis of participants receiving stavudine containing regimens.</p><p>**Cholesterol, liver function tests and creatinine for patients followed 72/73 weeks (all HAART regimens).</p>", "links"=>[], "tags"=>["infectious diseases/hiv infection and aids", "infectious diseases/viral infections", "public health and epidemiology/global health"], "article_id"=>523523, "categories"=>["Infectious Diseases", "Medicine", "Cancer"], "users"=>["Steven J. Reynolds", "Cissy Kityo", "Claire W. Hallahan", "Geoffrey Kabuye", "Diana Atwiine", "Frank Mbamanya", "Francis Ssali", "Robin Dewar", "Marybeth Daucher", "Richard T. Davey Jr", "Peter Mugyenyi", "Anthony S. Fauci", "Thomas C. Quinn", "Mark R. Dybul"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0010307.t002", "stats"=>{"downloads"=>0, "page_views"=>7, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Toxicity_/523523", "title"=>"Toxicity.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2010-04-22 00:58:43"}
  • {"files"=>["https://ndownloader.figshare.com/files/852958"], "description"=>"<p>The CD4+ T cell counts in the continuously treated (N = 40) and in the 5 days on/2 days off (N = 46) arms were similar at baseline (255 and 271/mm<sup>3</sup>, respectively, p = 0.85) and marginally different at week 72/73 (330 and 429/mm<sup>3</sup>, respectively, p = 0.08). B. The median paired difference in CD4+ T cells between baseline and week 72/73 was greater in the 5 days on/2 days off group (114/mm<sup>3</sup>) than in the continuously treated group (68/mm<sup>3</sup>). (p = 0.01). The lines across the box indicates the median values; the boxes contain the 25–75% interquartile range; and the whiskers extend to the highest and lowest values.</p>", "links"=>[], "tags"=>["cells", "completing"], "article_id"=>523412, "categories"=>["Infectious Diseases", "Medicine", "Cancer"], "users"=>["Steven J. Reynolds", "Cissy Kityo", "Claire W. Hallahan", "Geoffrey Kabuye", "Diana Atwiine", "Frank Mbamanya", "Francis Ssali", "Robin Dewar", "Marybeth Daucher", "Richard T. Davey Jr", "Peter Mugyenyi", "Anthony S. Fauci", "Thomas C. Quinn", "Mark R. Dybul"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0010307.g003", "stats"=>{"downloads"=>0, "page_views"=>4, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_A_Change_in_CD4_T_cells_for_participants_successfully_completing_72_73_weeks_/523412", "title"=>"A. Change in CD4+ T cells for participants successfully completing 72/73 weeks.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2010-04-22 00:56:52"}
  • {"files"=>["https://ndownloader.figshare.com/files/853018"], "description"=>"<p>Reverse Transcriptase Genotypic Resistance Among Participants with Virologic Failure.</p>", "links"=>[], "tags"=>["transcriptase", "genotypic", "virologic"], "article_id"=>523467, "categories"=>["Infectious Diseases", "Medicine", "Cancer"], "users"=>["Steven J. Reynolds", "Cissy Kityo", "Claire W. Hallahan", "Geoffrey Kabuye", "Diana Atwiine", "Frank Mbamanya", "Francis Ssali", "Robin Dewar", "Marybeth Daucher", "Richard T. Davey Jr", "Peter Mugyenyi", "Anthony S. Fauci", "Thomas C. Quinn", "Mark R. Dybul"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0010307.t003", "stats"=>{"downloads"=>0, "page_views"=>4, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Reverse_Transcriptase_Genotypic_Resistance_Among_Participants_with_Virologic_Failure_/523467", "title"=>"Reverse Transcriptase Genotypic Resistance Among Participants with Virologic Failure.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2010-04-22 00:57:47"}
  • {"files"=>["https://ndownloader.figshare.com/files/852881"], "description"=>"<p>No difference was found in the time to failure in the 2 groups during the 72/73 week study.</p>", "links"=>[], "tags"=>["infectious diseases/hiv infection and aids", "infectious diseases/viral infections", "public health and epidemiology/global health"], "article_id"=>523332, "categories"=>["Infectious Diseases", "Medicine", "Cancer"], "users"=>["Steven J. Reynolds", "Cissy Kityo", "Claire W. Hallahan", "Geoffrey Kabuye", "Diana Atwiine", "Frank Mbamanya", "Francis Ssali", "Robin Dewar", "Marybeth Daucher", "Richard T. Davey Jr", "Peter Mugyenyi", "Anthony S. Fauci", "Thomas C. Quinn", "Mark R. Dybul"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0010307.g002", "stats"=>{"downloads"=>0, "page_views"=>6, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Kaplan_Meier_Survival_Curve_with_Time_to_Failure_/523332", "title"=>"Kaplan-Meier Survival Curve with Time to Failure.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2010-04-22 00:55:32"}

PMC Usage Stats | Further Information

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