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Operationalizing Human Immunodeficiency Virus Cure-related Trials with Analytic Treatment Interruptions During the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Pandemic: A Collaborative Approach

Efforts to recognize and minimize the risk to study participants will be necessary to safely and ethically resume scientific research in the context of the ongoing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic. These efforts are uniquely challenging in the context of human im...

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Autores principales: Peluso, Michael J, Dee, Lynda, Shao, Shirley, Taylor, Jeff, Campbell, Danielle, Collins, Simon, Gandhi, Monica, Johnston, Rowena, Deeks, Steven G, Sauceda, John A, Dubé, Karine
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7499539/
https://www.ncbi.nlm.nih.gov/pubmed/32841311
http://dx.doi.org/10.1093/cid/ciaa1260
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author Peluso, Michael J
Dee, Lynda
Shao, Shirley
Taylor, Jeff
Campbell, Danielle
Collins, Simon
Gandhi, Monica
Johnston, Rowena
Deeks, Steven G
Sauceda, John A
Dubé, Karine
author_facet Peluso, Michael J
Dee, Lynda
Shao, Shirley
Taylor, Jeff
Campbell, Danielle
Collins, Simon
Gandhi, Monica
Johnston, Rowena
Deeks, Steven G
Sauceda, John A
Dubé, Karine
author_sort Peluso, Michael J
collection PubMed
description Efforts to recognize and minimize the risk to study participants will be necessary to safely and ethically resume scientific research in the context of the ongoing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic. These efforts are uniquely challenging in the context of human immunodeficiency virus (HIV) cure clinical trials, which often involve complex experimental therapy regimens and perhaps analytic treatment interruption, in which participants pause antiretroviral therapy. In this viewpoint, we discuss our approach to reopening an HIV cure trial in this context, with a focus on key considerations regarding study design, informed consent and participant education, and study implementation. These recommendations might be informative to other groups seeking to resume HIV cure research in settings similar to ours.
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spelling pubmed-74995392020-09-21 Operationalizing Human Immunodeficiency Virus Cure-related Trials with Analytic Treatment Interruptions During the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Pandemic: A Collaborative Approach Peluso, Michael J Dee, Lynda Shao, Shirley Taylor, Jeff Campbell, Danielle Collins, Simon Gandhi, Monica Johnston, Rowena Deeks, Steven G Sauceda, John A Dubé, Karine Clin Infect Dis Viewpoints Efforts to recognize and minimize the risk to study participants will be necessary to safely and ethically resume scientific research in the context of the ongoing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic. These efforts are uniquely challenging in the context of human immunodeficiency virus (HIV) cure clinical trials, which often involve complex experimental therapy regimens and perhaps analytic treatment interruption, in which participants pause antiretroviral therapy. In this viewpoint, we discuss our approach to reopening an HIV cure trial in this context, with a focus on key considerations regarding study design, informed consent and participant education, and study implementation. These recommendations might be informative to other groups seeking to resume HIV cure research in settings similar to ours. Oxford University Press 2020-08-25 /pmc/articles/PMC7499539/ /pubmed/32841311 http://dx.doi.org/10.1093/cid/ciaa1260 Text en © The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com. https://academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_modelThis article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model)
spellingShingle Viewpoints
Peluso, Michael J
Dee, Lynda
Shao, Shirley
Taylor, Jeff
Campbell, Danielle
Collins, Simon
Gandhi, Monica
Johnston, Rowena
Deeks, Steven G
Sauceda, John A
Dubé, Karine
Operationalizing Human Immunodeficiency Virus Cure-related Trials with Analytic Treatment Interruptions During the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Pandemic: A Collaborative Approach
title Operationalizing Human Immunodeficiency Virus Cure-related Trials with Analytic Treatment Interruptions During the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Pandemic: A Collaborative Approach
title_full Operationalizing Human Immunodeficiency Virus Cure-related Trials with Analytic Treatment Interruptions During the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Pandemic: A Collaborative Approach
title_fullStr Operationalizing Human Immunodeficiency Virus Cure-related Trials with Analytic Treatment Interruptions During the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Pandemic: A Collaborative Approach
title_full_unstemmed Operationalizing Human Immunodeficiency Virus Cure-related Trials with Analytic Treatment Interruptions During the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Pandemic: A Collaborative Approach
title_short Operationalizing Human Immunodeficiency Virus Cure-related Trials with Analytic Treatment Interruptions During the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Pandemic: A Collaborative Approach
title_sort operationalizing human immunodeficiency virus cure-related trials with analytic treatment interruptions during the severe acute respiratory syndrome coronavirus 2 (sars-cov-2) pandemic: a collaborative approach
topic Viewpoints
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7499539/
https://www.ncbi.nlm.nih.gov/pubmed/32841311
http://dx.doi.org/10.1093/cid/ciaa1260
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