Evidence map›Paper›PMID 30885693›Full record

ArticleThe lancet. HIV2019

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

Boris Julg, Lynda Dee, Jintanat Ananworanich, Dan H Barouch, Katharine Bar, Marina Caskey, Donn J Colby, Liza Dawson, Krista L Dong, Karine Dubé and 39 more

Abstract readConsensus Statement
PubMed Full text at PMC Publisher
In one paragraph

Article in The lancet. HIV, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 156 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
156citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

156 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
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  10. Time to Viral Rebound After Interruption of Modern Antiretroviral Therapies.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2022
    Trial
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96 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

49 authors.

Boris JulgRagon Institute of MGH, MIT and Harvard, Cambridge, MA, USA; Infectious Disease Division, Massachusetts General Hospital, Boston, MA, USA. Electronic address: bjulg@mgh.harvard.edu.
Lynda DeeAIDS Action Baltimore, Baltimore, MD, USA.
Jintanat AnanworanichUS Military HIV Research Program, Henry Jackson Foundation, Bethesda, MD, USA.
Dan H BarouchRagon Institute of MGH, MIT and Harvard, Cambridge, MA, USA; Beth Israel Deaconess Medical Center, Boston, MA, USA.
Katharine BarDepartment of Medicine, University of Pennsylvania, Pennsylvania, PA, USA.
Marina CaskeyLaboratory of Molecular Immunology, Rockefeller University, New York, NY, USA.
Donn J ColbyThai Red Cross AIDS Research Center, Bangkok, Thailand.
Liza DawsonNational Institute of Allergy and Infectious Diseases, Fishers ln Rockville, MD, USA.
Krista L DongRagon Institute of MGH, MIT and Harvard, Cambridge, MA, USA; University of KwaZulu Natal, Durban, South Africa.
Karine DubéGillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, USA.
Joseph EronDivision of Infectious Diseases, University of North Carolina, Chapel Hill, NC, USA.
John FraterNuffield Department of Medicine, University of Oxford, Oxford, UK; Oxford National Institute of Health Research Biomedical Research Centre, Oxford, UK.
Rajesh T GandhiInfectious Disease Division, Massachusetts General Hospital, Boston, MA, USA.
Romas GeleziunasGilead Sciences, Foster City, CA, USA.
Philip GoulderDepartment of Paediatrics, University of Oxford, Oxford, UK.
George J HannaMerck, Kenilworth, NJ, USA.
Richard JefferysTreatment Action Group, New York, NY, USA.
Rowena JohnstonamfAR, New York, NY, USA.
Daniel KuritzkesDivision of Infectious Diseases, Brigham and Women's Hospital, Cambridge, MA, USA.
Jonathan Z LiDivision of Infectious Diseases, Brigham and Women's Hospital, Cambridge, MA, USA.
Udom LikhitwonnawutAVAC: Global Advocacy for HIV Prevention, New York, NY, USA.
Jan van LunzenViiV Healthcare, Brentford, UK.
Javier Martinez-PicadoAIDS Research Institute IrsiCaixa, Barcelona, Spain; Catalan Institution for Research and Advanced Studies, Barcelona, Spain; University of Vic-Central University of Catalonia, Barcelona, Spain.
Veronica MillerForum for Collaborative Research, Washington, DC, USA.
Luis J MontanerThe Montaner Laboratory, The Wistar Institute, Philadelphia, PA, USA.
Douglas F NixonDivision of Infectious Diseases, Department of Medicine, Weill Cornell Medical College, New York City, NY, USA.
David PalmGlobal HIV Prevention, and Treatment Clinical Trials Unit, University of North Carolina, Chapel Hill, NC, USA.
Giuseppe PantaleoService Immunology and Allergy, and Swiss Vaccine Research Institute, Centre Hospitalier Universitaire, Lausanne, Switzerland.
Holly PeayResearch Triangle Institute, Research Triangle Park, NC, USA.
Deborah PersaudPediatrics Infectious Disease, School of Medicine, University of North Carolina, Chapel Hill, NC, USA.
Jessica SalzwedelAVAC: Global Advocacy for HIV Prevention, New York, NY, USA.
Karl SalzwedelNational Institute of Allergy and Infectious Diseases, Fishers ln Rockville, MD, USA.
Timothy SchackerDivision of Infectious Disease and International Medicine, University of Minnesota, Minneapolis, MN, USA.
Virginia SheikhDivision of Antiviral Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Ole S SøgaardDepartment of Infectious Diseases, Aarhus University, Aarhus, Denmark.
Serena SpudichDepartment of Neurology, Yale University, New Haven, CT, USA.
Kathryn StephensonRagon Institute of MGH, MIT and Harvard, Cambridge, MA, USA; Beth Israel Deaconess Medical Center, Boston, MA, USA.
Jeremy SugarmanBerman Institute of Bioethics, University of North Carolina, Chapel Hill, NC, USA.
Jeff TaylorCollaboratory for AIDS Researchers for Eradication, University of North Carolina, Chapel Hill, NC, USA.
Pablo TebasPerelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Caroline T TiemessenCell Biology Research Laboratory, Centre for HIV and STIs, National Institute for Communicable Diseases, Johannesburg, South Africa; Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Randall TresslerNational Institute of Allergy and Infectious Diseases, Fishers ln Rockville, MD, USA.
Carol D WeissDivision of Antiviral Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Lu ZhengDepartment of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA, USA.
Merlin L RobbUS Military HIV Research Program, Henry Jackson Foundation, Bethesda, MD, USA.
Nelson L MichaelUS Military HIV Research Program, Henry Jackson Foundation, Bethesda, MD, USA.
John W MellorsDivision of Infectious Diseases, Department of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.
Steven G DeeksSchool of Medicine, University of California San Francisco, San Francisco, CA, USA.
Bruce D WalkerRagon Institute of MGH, MIT and Harvard, Cambridge, MA, USA; Howard Hughes Medical Institute, Chevy Chase, MD, USA.

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
Virology CoreP30AI027763 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI MALLORY O JOHNSON · 1988 to 2026
$93.6M
Collaboratory of AIDS Researchers for Eradication (CARE)UM1AI126619 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI MARGOLIS, DAVID M. · 2016 to 2020
$23.2M
Optimizing HIV-specific T-cell responses by therapeutic vaccinationR01AI138790 · NIAID · MASSACHUSETTS GENERAL HOSPITAL · PI JUELG, BORIS DOMINIK · 2019 to 2024
$2.8M
Maximising Cure Potential in Paediatric HIV InfectionR01AI133673 · NIAID · UNIVERSITY OF OXFORD · PI GOULDER, PHILIP J · 2017 to 2021
$1.4M
Vaccine induced T-cell protection against SIV infectionK08AI106408 · NIAID · MASSACHUSETTS GENERAL HOSPITAL · PI JUELG, BORIS DOMINIK · 2013 to 2017
$938k
Diversity of Immune Responses Elicited by HIV VaccinesK23AI114381 · NIAID · BETH ISRAEL DEACONESS MEDICAL CENTER · PI STEPHENSON, KATHRYN ELAINE · 2014 to 2018
$818k
Pilot Integration of Participant-Centered Outcomes in HIV Cure Research in the United States: Implications for Ethical ConductR21MH118120 · NIMH · UNIV OF NORTH CAROLINA CHAPEL HILL · PI DUBE, KARINE · 2019 to 2020
$566k
Medical Research Council MR/L006588/1NCATS NIH HHS UL1 TR001863NIAID NIH HHS K08 AI106408NIAID NIH HHS K23 AI114381NIAID NIH HHS P30 AI027763NIAID NIH HHS R01 AI133673NIAID NIH HHS R01 AI138790NIAID NIH HHS UM1 AI126619NIMH NIH HHS R21 MH118120
6 · The paper itself

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.

Indexed as

Anti-Retroviral AgentsHIV InfectionsHumansSustained Virologic ResponseViral LoadWithholding TreatmentAnti-Retroviral Agents

Identifiers

PMID30885693
PMCPMC6688772

What OpenQuestion holds

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Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.