Recommendations for analytical antiretroviral treatment interruptions in HIV research trials-report of a consensus meeting.

Details

Serval ID
serval:BIB_D9BACB56B9AE
Type
Article: article from journal or magazin.
Publication sub-type
Review (review): journal as complete as possible of one specific subject, written based on exhaustive analyses from published work.
Collection
Publications
Institution
Title
Recommendations for analytical antiretroviral treatment interruptions in HIV research trials-report of a consensus meeting.
Journal
The lancet. HIV
Author(s)
Julg B., Dee L., Ananworanich J., Barouch D.H., Bar K., Caskey M., Colby D.J., Dawson L., Dong K.L., Dubé K., Eron J., Frater J., Gandhi R.T., Geleziunas R., Goulder P., Hanna G.J., Jefferys R., Johnston R., Kuritzkes D., Li J.Z., Likhitwonnawut U., van Lunzen J., Martinez-Picado J., Miller V., Montaner L.J., Nixon D.F., Palm D., Pantaleo G., Peay H., Persaud D., Salzwedel J., Salzwedel K., Schacker T., Sheikh V., Søgaard O.S., Spudich S., Stephenson K., Sugarman J., Taylor J., Tebas P., Tiemessen C.T., Tressler R., Weiss C.D., Zheng L., Robb M.L., Michael N.L., Mellors J.W., Deeks S.G., Walker B.D.
ISSN
2352-3018 (Electronic)
ISSN-L
2352-3018
Publication state
Published
Issued date
04/2019
Peer-reviewed
Oui
Volume
6
Number
4
Pages
e259-e268
Language
english
Notes
Publication types: Consensus Development Conference ; Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
Publication Status: ppublish
Abstract
Analytical antiretroviral treatment interruption (ATI) is an important feature of HIV research, seeking to achieve sustained viral suppression in the absence of antiretroviral therapy (ART) when the goal is to measure effects of novel therapeutic interventions on time to viral load rebound or altered viral setpoint. Trials with ATIs also intend to determine host, virological, and immunological markers that are predictive of sustained viral control off ART. Although ATI is increasingly incorporated into proof-of-concept trials, no consensus has been reached on strategies to maximise its utility and minimise its risks. In addition, differences in ATI trial designs hinder the ability to compare efficacy and safety of interventions across trials. Therefore, we held a meeting of stakeholders from many interest groups, including scientists, clinicians, ethicists, social scientists, regulators, people living with HIV, and advocacy groups, to discuss the main challenges concerning ATI studies and to formulate recommendations with an emphasis on strategies for risk mitigation and monitoring, ART resumption criteria, and ethical considerations. In this Review, we present the major points of discussion and consensus views achieved with the goal of informing the conduct of ATIs to maximise the knowledge gained and minimise the risk to participants in clinical HIV research.
Keywords
Anti-Retroviral Agents/administration & dosage, HIV Infections/drug therapy, Humans, Sustained Virologic Response, Viral Load, Withholding Treatment/standards
Pubmed
Web of science
Create date
09/04/2019 7:22
Last modification date
26/06/2020 5:21
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