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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...
Autores principales: | , , , , , , , , , , , , , |
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Formato: | Texto |
Lenguaje: | English |
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Public Library of Science
2010
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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 |
format | Text |
id | pubmed-2860845 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2010 |
publisher | Public Library of Science |
record_format | MEDLINE/PubMed |
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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