Analytical Treatment Interruption in HIV Trials: Statistical and Study Design Considerations

PURPOSE OF REVIEW: Analytical treatment interruption (ATI) remains an essential component in clinical studies investigating novel agents or combination treatment strategies aiming to induce HIV treatment-free remission or long-term viral control. We provide an overview on key study design aspects of...

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Autores principales: Zheng, Lu, Tierney, Camlin, Bosch, Ronald J
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer US 2021
Materias:
HIV Pathogenesis and Treatment (AL Landay and NS Utay, Section Editors)
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8251690/
https://www.ncbi.nlm.nih.gov/pubmed/34213731
http://dx.doi.org/10.1007/s11904-021-00569-8
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author Zheng, Lu
Tierney, Camlin
Bosch, Ronald J
author_facet Zheng, Lu
Tierney, Camlin
Bosch, Ronald J
author_sort Zheng, Lu
collection PubMed
description PURPOSE OF REVIEW: Analytical treatment interruption (ATI) remains an essential component in clinical studies investigating novel agents or combination treatment strategies aiming to induce HIV treatment-free remission or long-term viral control. We provide an overview on key study design aspects of ATI trials from the perspective of statisticians. RECENT FINDINGS: ATI trial designs have evolved towards shorter treatment interruption phases and more frequent viral load monitoring aiming to reduce prolonged viremia risks. Criteria for ART resumption have evolved as well. Common outcome measures in modern ATI trials include time to viral rebound, viral control, and viral set point. SUMMARY: Design of the ATI component in HIV clinical trials is driven by the scientific question and the mechanism of action of the intervention being investigated.
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spelling pubmed-82516902021-07-02 Analytical Treatment Interruption in HIV Trials: Statistical and Study Design Considerations Zheng, Lu Tierney, Camlin Bosch, Ronald J Curr HIV/AIDS Rep HIV Pathogenesis and Treatment (AL Landay and NS Utay, Section Editors) PURPOSE OF REVIEW: Analytical treatment interruption (ATI) remains an essential component in clinical studies investigating novel agents or combination treatment strategies aiming to induce HIV treatment-free remission or long-term viral control. We provide an overview on key study design aspects of ATI trials from the perspective of statisticians. RECENT FINDINGS: ATI trial designs have evolved towards shorter treatment interruption phases and more frequent viral load monitoring aiming to reduce prolonged viremia risks. Criteria for ART resumption have evolved as well. Common outcome measures in modern ATI trials include time to viral rebound, viral control, and viral set point. SUMMARY: Design of the ATI component in HIV clinical trials is driven by the scientific question and the mechanism of action of the intervention being investigated. Springer US 2021-07-02 2021 /pmc/articles/PMC8251690/ /pubmed/34213731 http://dx.doi.org/10.1007/s11904-021-00569-8 Text en © The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature 2021 This article is made available via the PMC Open Access Subset for unrestricted research re-use and secondary analysis in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the World Health Organization (WHO) declaration of COVID-19 as a global pandemic.
spellingShingle HIV Pathogenesis and Treatment (AL Landay and NS Utay, Section Editors)
Zheng, Lu
Tierney, Camlin
Bosch, Ronald J
Analytical Treatment Interruption in HIV Trials: Statistical and Study Design Considerations
title Analytical Treatment Interruption in HIV Trials: Statistical and Study Design Considerations
title_full Analytical Treatment Interruption in HIV Trials: Statistical and Study Design Considerations
title_fullStr Analytical Treatment Interruption in HIV Trials: Statistical and Study Design Considerations
title_full_unstemmed Analytical Treatment Interruption in HIV Trials: Statistical and Study Design Considerations
title_short Analytical Treatment Interruption in HIV Trials: Statistical and Study Design Considerations
title_sort analytical treatment interruption in hiv trials: statistical and study design considerations
topic HIV Pathogenesis and Treatment (AL Landay and NS Utay, Section Editors)
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8251690/
https://www.ncbi.nlm.nih.gov/pubmed/34213731
http://dx.doi.org/10.1007/s11904-021-00569-8
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