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

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 ≥125 cells/mm...

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Autores principales: Reynolds, Steven J., Kityo, Cissy, Hallahan, Claire W., Kabuye, Geoffrey, Atwiine, Diana, Mbamanya, Frank, Ssali, Francis, Dewar, Robin, Daucher, Marybeth, Davey, Richard T., Mugyenyi, Peter, Fauci, Anthony S., Quinn, Thomas C., Dybul, Mark R.
Formato: Texto
Lenguaje:English
Publicado: Public Library of Science 2010
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2860845/
https://www.ncbi.nlm.nih.gov/pubmed/20442758
http://dx.doi.org/10.1371/journal.pone.0010307
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author Reynolds, Steven J.
Kityo, Cissy
Hallahan, Claire W.
Kabuye, Geoffrey
Atwiine, Diana
Mbamanya, Frank
Ssali, Francis
Dewar, Robin
Daucher, Marybeth
Davey, Richard T.
Mugyenyi, Peter
Fauci, Anthony S.
Quinn, Thomas C.
Dybul, Mark R.
author_facet Reynolds, Steven J.
Kityo, Cissy
Hallahan, Claire W.
Kabuye, Geoffrey
Atwiine, Diana
Mbamanya, Frank
Ssali, Francis
Dewar, Robin
Daucher, Marybeth
Davey, Richard T.
Mugyenyi, Peter
Fauci, Anthony S.
Quinn, Thomas C.
Dybul, Mark R.
author_sort Reynolds, Steven J.
collection PubMed
description 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 ≥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
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spelling pubmed-28608452010-05-04 A Randomized, Controlled, Trial of Short Cycle Intermittent Compared to Continuous Antiretroviral Therapy for the Treatment of HIV Infection in Uganda Reynolds, Steven J. Kityo, Cissy Hallahan, Claire W. Kabuye, Geoffrey Atwiine, Diana Mbamanya, Frank Ssali, Francis Dewar, Robin Daucher, Marybeth Davey, Richard T. Mugyenyi, Peter Fauci, Anthony S. Quinn, Thomas C. Dybul, Mark R. PLoS One Research Article 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 ≥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 Public Library of Science 2010-04-22 /pmc/articles/PMC2860845/ /pubmed/20442758 http://dx.doi.org/10.1371/journal.pone.0010307 Text en This is an open-access article distributed under the terms of the Creative Commons Public Domain declaration which stipulates that, once placed in the public domain, this work may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. https://creativecommons.org/publicdomain/zero/1.0/ This is an open-access article distributed under the terms of the Creative Commons Public Domain declaration, which stipulates that, once placed in the public domain, this work may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose.
spellingShingle Research Article
Reynolds, Steven J.
Kityo, Cissy
Hallahan, Claire W.
Kabuye, Geoffrey
Atwiine, Diana
Mbamanya, Frank
Ssali, Francis
Dewar, Robin
Daucher, Marybeth
Davey, Richard T.
Mugyenyi, Peter
Fauci, Anthony S.
Quinn, Thomas C.
Dybul, Mark R.
A Randomized, Controlled, Trial of Short Cycle Intermittent Compared to Continuous Antiretroviral Therapy for the Treatment of HIV Infection in Uganda
title A Randomized, Controlled, Trial of Short Cycle Intermittent Compared to Continuous Antiretroviral Therapy for the Treatment of HIV Infection in Uganda
title_full A Randomized, Controlled, Trial of Short Cycle Intermittent Compared to Continuous Antiretroviral Therapy for the Treatment of HIV Infection in Uganda
title_fullStr A Randomized, Controlled, Trial of Short Cycle Intermittent Compared to Continuous Antiretroviral Therapy for the Treatment of HIV Infection in Uganda
title_full_unstemmed A Randomized, Controlled, Trial of Short Cycle Intermittent Compared to Continuous Antiretroviral Therapy for the Treatment of HIV Infection in Uganda
title_short A Randomized, Controlled, Trial of Short Cycle Intermittent Compared to Continuous Antiretroviral Therapy for the Treatment of HIV Infection in Uganda
title_sort randomized, controlled, trial of short cycle intermittent compared to continuous antiretroviral therapy for the treatment of hiv infection in uganda
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2860845/
https://www.ncbi.nlm.nih.gov/pubmed/20442758
http://dx.doi.org/10.1371/journal.pone.0010307
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