Alex P. Salam, MBChB, MSc; Amanda Rojek, MBBS, MSc; Jake Dunning, MBBS, PhD; Peter W. Horby, MBBS PhD
Acknowledgment: The authors thank Emmanuelle Denis for the figure.
Grant Support: Peter Horby is supported by the Wellcome Trust of Great Britain (grants 107834/Z/15/Z and 106491/Z/14/Z), European Union FP7 project PREPARE (Platform for European Preparedness Against [Re-]emerging Epidemics; grant 602525), and Medical Research Council UK (MC_PC_15001). Dr. Rojek is funded by a Rhodes Scholarship.
Disclosures: Authors have disclosed no conflicts of interest. Forms can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M16-2530.
Requests for Single Reprints: Alex Salam, MBChB, MSc, Epidemic Diseases Research Group Oxford, Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine Research Building, University of Oxford, Old Road Campus, Roosevelt Drive, Oxford OX3 7FZ, United Kingdom; e-mail, firstname.lastname@example.org.
Current Author Addresses: Drs. Salam, Rojek, Dunning, and Horby: Epidemic Diseases Research Group Oxford, Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine Research Building, University of Oxford, Old Road Campus, Roosevelt Drive, Oxford OX3 7FZ, United Kingdom.
Author Contributions: Conception and design: A.P. Salam, A. Rojek, J. Dunning, P.W. Horby.
Analysis and interpretation of the data: A.P. Salam, A. Rojek.
Drafting of the article: A.P. Salam, A. Rojek, J. Dunning, P.W. Horby.
Critical revision for important intellectual content: A.P. Salam, A. Rojek, J. Dunning, P.W. Horby.
Final approval of the article: A.P. Salam, A. Rojek, J. Dunning, P.W. Horby.
Collection and assembly of data: A.P. Salam, A. Rojek.
Zika virus (ZIKV) infection in pregnancy is associated with adverse fetal outcomes, such as microcephaly and other congenital malformations. No therapeutic options are available to pregnant women with ZIKV infection to prevent these effects. Drug trials in pregnancy raise several scientific, ethical, and logistic challenges, which are compounded further in ZIKV because of limited knowledge of the disease pathophysiology and a product development pipeline in its infancy. We evaluate the major challenges in choosing therapeutics to prevent congenital ZIKV disease and conducting clinical trials of these treatments, with a focus on preventing congenital central nervous system malformations. These challenges must be characterized and planned for now so that clinical trials can progress expediently and effectively in the future.
Theoretical mechanisms underlying Zika virus disruption of central nervous system development.
Table 1. Suggested Enrollment Criteria
Table 2. Key Considerations and Recommendations
The In the Clinic® slide sets are owned and copyrighted by the American College of Physicians (ACP). All text, graphics, trademarks, and other intellectual property incorporated into the slide sets remain the sole and exclusive property of the ACP. The slide sets may be used only by the person who downloads or purchases them and only for the purpose of presenting them during not-for-profit educational activities. Users may incorporate the entire slide set or selected individual slides into their own teaching presentations but may not alter the content of the slides in any way or remove the ACP copyright notice. Users may make print copies for use as hand-outs for the audience the user is personally addressing but may not otherwise reproduce or distribute the slides by any means or media, including but not limited to sending them as e-mail attachments, posting them on Internet or Intranet sites, publishing them in meeting proceedings, or making them available for sale or distribution in any unauthorized form, without the express written permission of the ACP. Unauthorized use of the In the Clinic slide sets will constitute copyright infringement.
Faculty of Sciences Universidad Nacional Autónoma de México
May 8, 2017
ZIKV: clinical trials.
To the editor:
ZIKV: clinical trials.
I have read the very interesting article by Salam and colleagues (1) [Clinical Trials of Therapeutics for the Prevention of Congenital Zika Virus Disease: Challenges and Potential Solutions, Annals of Internal Medicine], discuss the ZIKV clinical trials, its characterization and planning.
In my view, is necessary to create/update a unique Public Database of pregnant women under ZIKV clinical trials. The knowledge about the future behavior of ZIKV vector, as well as other consequences of this disease is unknown. The information should be shared.
Carlos Polanco, Ph.D., D.Sc.
Universidad Nacional Autónoma de México, México City, México.
Carlos Polanco is an Associate Professor at the Department of Mathematics in the Universidad Nacional Autónoma de México, México City, México.
1. Salam AP, Rojek A, Dumming J, Horby PW. Clinical Trials of Therapeutics for the Prevention of Congenital Zika Virus Disease: Challenges and Potential Solutions, Annals of Internal Medicine 2017. DOI: 10.7326/M16-2530.
Salam AP, Rojek A, Dunning J, Horby PW. Clinical Trials of Therapeutics for the Prevention of Congenital Zika Virus Disease: Challenges and Potential Solutions. Ann Intern Med. ;166:725–732. doi: 10.7326/M16-2530
Download citation file:
Published: Ann Intern Med. 2017;166(10):725-732.
Published at www.annals.org on 21 March 2017
Research and Reporting Methods.
Results provided by:
Copyright © 2018 American College of Physicians. All Rights Reserved.
Print ISSN: 0003-4819 | Online ISSN: 1539-3704
Conditions of Use