Abdel G. Babiker

ORCID: 0000-0003-4711-3021
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Research Areas
  • HIV/AIDS Research and Interventions
  • HIV Research and Treatment
  • HIV/AIDS drug development and treatment
  • SARS-CoV-2 and COVID-19 Research
  • COVID-19 Clinical Research Studies
  • Long-Term Effects of COVID-19
  • Statistical Methods in Clinical Trials
  • Advanced Causal Inference Techniques
  • Health Systems, Economic Evaluations, Quality of Life
  • Advanced Topology and Set Theory
  • SARS-CoV-2 detection and testing
  • Statistical Methods and Bayesian Inference
  • Statistical Methods and Inference
  • Advanced Banach Space Theory
  • HIV-related health complications and treatments
  • Global Maternal and Child Health
  • Pneumocystis jirovecii pneumonia detection and treatment
  • Rings, Modules, and Algebras
  • Adolescent and Pediatric Healthcare
  • Housing Market and Economics
  • Ethics in Clinical Research
  • Viral-associated cancers and disorders
  • Financial Literacy, Pension, Retirement Analysis
  • Child Nutrition and Water Access
  • Algebraic structures and combinatorial models

University College London
2015-2024

Medical Research Council
2015-2024

MRC Clinical Trials Unit at UCL
1997-2023

Australian National University
2022

University Medical Center
2020

University of Copenhagen
2020

Rigshospitalet
2020

Gentofte Hospital
2020

Aarhus University Hospital
2020

Baylor University
2020

BackgroundAlthough several therapeutic agents have been evaluated for the treatment of coronavirus disease 2019 (Covid-19), no antiviral yet shown to be efficacious.MethodsWe conducted a double-blind, randomized, placebo-controlled trial intravenous remdesivir in adults who were hospitalized with Covid-19 and had evidence lower respiratory tract infection. Patients randomly assigned receive either (200 mg loading dose on day 1, followed by 100 daily up 9 additional days) or placebo 10 days....

10.1056/nejmoa2007764 article EN New England Journal of Medicine 2020-05-22

BackgroundLY-CoV555, a neutralizing monoclonal antibody, has been associated with decrease in viral load and the frequency of hospitalizations or emergency department visits among outpatients coronavirus disease 2019 (Covid-19). Data are needed on effect this antibody patients who hospitalized Covid-19.MethodsIn platform trial therapeutic agents, we randomly assigned had Covid-19 without end-organ failure 1:1 ratio to receive either LY-CoV555 matching placebo. In addition, all received...

10.1056/nejmoa2033130 article EN New England Journal of Medicine 2020-12-22
Wesley H. Self Uriel Sandkovsky Cavan Reilly David M. Vock Robert Gottlieb and 95 more M. Mack Kevin Golden Emma Dishner Andrew M. Vekstein Emily R. Ko Tatyana Der John Franzone Eyad Almasri Mohamed Fayed Michael R. Filbin Kathryn A. Hibbert Todd W. Rice Jonathan D. Casey J.W. Awori Hayanga Vinay Badhwar Bradley G. Leshnower Milad Sharifpour Kirk U. Knowlton Ithan D. Peltan Elizieta Bakowska Justyna D. Kowalska Michael E. Bowdish Jeffrey M. Sturek Angela J. Rogers D. Clark Files Jarrod Mosier Michelle N. Gong David J. Douin R. Duncan Hite Barbara W. Trautner Mamta K. Jain Edward M. Gardner Akram Khan Jens‐Ulrik Stæhr Jensen Michael A. Matthay Adit A. Ginde Samuel M. Brown Elizabeth S. Higgs Sarah Pett Amy Weintrob Christina C. Chang Daniel D. Murrary Huldrych F. Günthard Ellen Moquete Greg Grandits Nicole Engen Birgit Grund Shweta Sharma Huyen Cao Rajesh Gupta Suzette Y. Osei David M. Margolis Qing Zhu Mark N. Polizzotto Abdel G. Babiker Victoria J. Davey Virginia L. Kan Bruce Thompson Annetine C. Gelijns James D. Neaton H. Clifford Lane Jens D. Jundgren John Tierney Kevin Barrett Betsey Herpin Mary Smolskis Susan E. Voge Laura A. McNay Kelly Cahill Page Crew Matthew Kirchoff Ratna Sardana Sharon Segal Raim Joseph Chiu Lisa E. Hensley J. A. Lorenzo Rebecca Mock Kathryn Shaw‐Saliba Judith Zuckerman Stacey J. Adam Judy Currier Sarah Read Eric Hughes Laura Amos Amy Carlsen Anita Carter Bionca Davis Eileen Denning Alain DuChêne Merrie Harrison Payton Kaiser Joseph S. Koopmeiners Sue Meger Thomas A. Murray Kien Quan

10.1016/s1473-3099(21)00751-9 article EN The Lancet Infectious Diseases 2021-12-24
Thomas L Holland Adit A. Ginde Roger Paredes Thomas A. Murray Nicole Engen and 95 more Greg Grandits Andrew M. Vekstein Noel Ivey Ahmad Mourad Uriel Sandkovsky Robert Gottlieb Mezgebe Berhe Mamta K. Jain Rubria Marines‐Price Barbine Tchamba Agbor Agbor Lourdes Mateu Sergio España-Cueto Gemma Lladós Eleftherios Mylonakis Ralph Rogers Fadi Shehadeh Michael R. Filbin Kathryn A. Hibbert Kami Kim Thanh Tran Peter E. Morris Evan Cassity Barbara W. Trautner Lavannya M. Pandit Kirk U. Knowlton Lindsay Leither Michael A. Matthay Angela J. Rogers Wonder Drake Beatrice Jones Garyphallia Poulakou Konstantinos N. Syrigos Eduardo Fernández‐Cruz Marisa Di Natale Eyad Almasri Leire Balerdi-Sarasola Sanjay Bhagani Katherine L. Boyle Jonathan D. Casey Peter Chen David J. Douin D. Clark Files Huldrych F. Günthard R. Duncan Hite Robert C. Hyzy Akram Khan Moses Kibirige Robert Kidega Ivan Kimuli Francis Kiweewa Jens‐Ulrik Stæhr Jensen Bradley G. Leshnower Joseph Lutaakome Prasad Manian Vidya Menon José Luís Morales‐Rull D. Shane O’Mahony J. Scott Overcash Srikant Ramachandruni Jay S. Steingrub Hassan S. Taha Michael R. Waters Barnaby Edward Young Andrew Phillips Daniel D. Murray Tomas Ø. Jensen María L. Padilla David Sahner Kathryn Shaw‐Saliba Robin Dewar Marc Teitelbaum Ven Natarajan M. Tauseef Rehman Sarah Pett Fleur Hudson Giota Touloumi Samuel M. Brown Wesley H. Self Christina C. Chang Adriana Sánchez Amy Weintrob Timothy Hatlen Birgit Grund Shweta Sharma Cavan Reilly Pedro Garbes Mark T. Esser Alison Templeton Abdel G. Babiker Victoria J. Davey Annetine C. Gelijns Elizabeth S. Higgs Virginia L. Kan Gail Matthews Bruce Thompson

10.1016/s2213-2600(22)00215-6 article EN publisher-specific-oa The Lancet Respiratory Medicine 2022-07-08

Abstract A case‐control study comprising 216 cases of pancreatic cancer and 279 controls was conducted to investigate the relationship with certain chronic medical conditions consumption tea, coffee alcoholic beverages. Significant positive associations preexisting diabetes mellitus gall‐bladder disease were observed there weak evidence association liver disease. The relative risks for gallstones diagnosed at least one year previously 4.1 ( p = 0.005) 2.8 0.01) respectively. Cases drank...

10.1002/ijc.2910430312 article EN International Journal of Cancer 1989-03-15

Untreated human immunodeficiency virus (HIV) infection is characterized by progressive depletion of CD4+ T lymphocyte (CD4) count leading to the development opportunistic diseases (acquired syndrome (AIDS)), and more recent data suggest that HIV also associated with an increased risk serious non-AIDS (SNA) including cardiovascular, renal, liver non-AIDS-defining cancers. Although combination antiretroviral treatment (ART) has resulted in a substantial decrease morbidity mortality persons...

10.1177/1740774512440342 article EN Clinical Trials 2012-04-30
Richard T. Davey Eduardo Fernández‐Cruz Norman Markowitz Sarah Pett Abdel G. Babiker and 95 more Deborah Wentworth Surender Khurana Nicole Engen Fred M. Gordin Mamta K. Jain Virginia L. Kan Mark N. Polizzotto Paul Riska Kiat Ruxrungtham Zelalem Temesgen Jens Lundgren John H. Beigel H. Clifford Lane James D. Neaton Richard T. Davey Eduardo Fernández‐Cruz Norman Markowitz Sarah Pett Abdel G. Babiker Deborah Wentworth Surender Khurana Nicole Engen Fred M. Gordin Mamta K. Jain Virginia L. Kan Mark N. Polizzotto Paul Riska Kiat Ruxrungtham Zelalem Temesgen Jens Lundgren John H. Beigel H. Clifford Lane James D. Neaton Jessica Butts Eileen Denning Alain DuChêne Eric Krum Merrie Harrison Sue Meger Ross L Peterson Kien Quan Megan Shaughnessy Bruce Thompson David M. Vock Julia A. Metcalf Robin Dewar Tauseef Ur Rehman Ven Natarajan Rose McConnell Emily M. Flowers Kenny Smith Marie L. Hoover Elizabeth M. Coyle David J. Munroe Bitten Aagaard Mary Pearson Adam Cursley Helen Webb Fleur Hudson Charlotte Russell Aminata Sy Cara Purvis Brooke Jackson Yolanda Collaço‐Moraes Dianne Carey Rosemary Robson Adriana Sánchez Elizabeth Finley Donna Sepulveda Conwell Marcelo Losso Luciana Gambardella Cecilia Abela Paco Lopez Helena Alonso Giota Touloumi Vicky Gioukari Olga Anagnostou Anchalee Avihingsanon Kanitta Pussadee Sasiwimol Ubolyam Bola Omotosho Clemencia Solórzano Tianna Petersen Kranthi Vysyaraju Stacey A. Rizza Jennifer A. Whitaker Raquel Nahra John D. Baxter Patricia Coburn Edward M. Gardner James Scott Leslie Faber E. Pastor Linda Makohon Rodger A MacArthur

BackgroundSince the 1918 influenza pandemic, non-randomised studies and small clinical trials have suggested that convalescent plasma or anti-influenza hyperimmune intravenous immunoglobulin (hIVIG) might benefit for patients with infection, but definitive data do not exist. We aimed to evaluate safety efficacy of hIVIG in a randomised controlled trial.MethodsThis randomised, double-blind, placebo-controlled trial was planned 45 hospitals Argentina, Australia, Denmark, Greece, Mexico, Spain,...

10.1016/s2213-2600(19)30253-x article EN cc-by-nc-nd The Lancet Respiratory Medicine 2019-09-30

10.1016/s0140-6736(22)00101-5 article EN publisher-specific-oa The Lancet 2022-01-28
Jens Lundgren Birgit Grund Christina E. Barkauskas Thomas L Holland Robert Gottlieb and 95 more Uriel Sandkovsky Samuel M. Brown Kirk U. Knowlton Wesley H. Self D. Clark Files Mamta K. Jain Thomas Benfield Michael E. Bowdish Bradley G. Leshnower Jason V. Baker Jens‐Ulrik Stæhr Jensen Edward M. Gardner Adit A. Ginde Estelle S. Harris Işık Somuncu Johansen Norman Markowitz Michael A. Matthay Lars Østergaard Christina C. Chang Anna L. Goodman Weizhong Chang Robin Dewar Norman P. Gerry Elizabeth S. Higgs Helene Highbarger Daniel D. Murray Thomas A. Murray Ven Natarajan Roger Paredes Mahesh Parmar Andrew Phillips Cavan Reilly Adam Rupert Shweta Sharma Kathryn Shaw‐Saliba Brad T. Sherman Marc Teitelbaum Deborah Wentworth Huyen Cao Paul Klekotka Abdel G. Babiker Victoria J. Davey Annetine C. Gelijns Virginia L. Kan Mark N. Polizzotto B. Taylor Thompson H. Clifford Lane James D. Neaton H. Clifford Lane John T. Tierney Elizabeth S. Higgs Kevin Barrett Betsey Herpin Mary Smolskis Susan Vogel Laura A. McNay Kelly Cahill Page Crew Matthew Kirchoff Ratna Sardana Sharon Segal Raim Kathryn Shaw‐Saliba Stacey J. Adam Sarah Read Eric Hughes Rachel H. Harrigan R. Baseler Marc Teitelbaum Shelly Simpson M J Buehn David Vallée Vanessa Eccard-Koons Stacey Kopka Theresa Engel Cynthia R. Osborne Leah MacDonald Liam Harmon Denise Shelley Mi Ha Kim Joy Beeler-Knights Lindsey Yeon Robin Dewar Ven Natarajan Weizhong Chang Brad T. Sherman Adam Rupert Helene Highbarger Michael Baseler Perrine Lallemand Tauseef Ur Rehman Danielle Lynam Gregg Mendez Tomozumi Imamichi Sylvain Laverdure Sharada Paudel

In a randomized, placebo-controlled, clinical trial, bamlanivimab, SARS-CoV-2-neutralizing monoclonal antibody, given in combination with remdesivir, did not improve outcomes among hospitalized patients COVID-19 based on an early futility assessment.

10.7326/m21-3507 article EN Annals of Internal Medicine 2021-12-20
Ralph Rogers Deborah Wentworth Andrew Phillips Kathryn Shaw‐Saliba Robin Dewar and 95 more Neil R. Aggarwal Abdel G. Babiker Weizhong Chang Nila J. Dharan Victoria J. Davey Elizabeth S. Higgs Norman P. Gerry Adit A. Ginde J.W. Awori Hayanga Helene Highbarger Jeroen Highbarger Mamta K. Jain Virginia L. Kan Kami Kim Perrine Lallemand Bradley G. Leshnower Joseph Lutaakome Gail Matthews Ahmad Mourad Eleftherios Mylonakis Ven Natarajan María L. Padilla Lavannya M. Pandit Roger Paredes Sarah Pett Srikanth Ramachandruni M. Tauseef Rehman Brad T. Sherman D. Clark Files Samuel M. Brown Michael A. Matthay B. Taylor Thompson James D. Neaton H. Clifford Lane Jens Lundgren Ralph Rogers Deborah Wentworth Andrew Phillips Kathryn Shaw‐Saliba Robin Dewar Neil R. Aggarwal Abdel G. Babiker Weizhong Chang Nila J. Dharan Victoria J. Davey Elizabeth S. Higgs Norman P. Gerry Adit A. Ginde J.W. Awori Hayanga Helene Highbarger Jeroen Highbarger Mamta K. Jain Virginia L. Kan Kami Kim Perrine Lallemand Bradley G. Leshnower Joseph Lutaakome Gail Matthews Ahmad Mourad Eleftherios Mylonakis Ven Natarajan María L. Padilla Lavannya M. Pandit Roger Paredes Sarah Pett Srikanth Ramachandruni M. Tauseef Rehman Brad T. Sherman D. Clark Files Samuel M. Brown Michael A. Matthay B. Taylor Thompson James D. Neaton H. Clifford Lane Jens Lundgren David Sahner John Tierney Susan Vogel Betsey Herpin Mary Smolskis Laura A McKay Kelly Cahill Page Crew Ratna Sardana Sharon Segal Raim Lisa Hensely J. Ponce Lorenzo Rebecca Mock Judith Zuckerman Negin Atri Mark D. Miller David Vallée Lucy Chung Nayon Kang Kevin Barrett

Background: Levels of plasma SARS-CoV-2 nucleocapsid (N) antigen may be an important biomarker in patients with COVID-19 and enhance our understanding the pathogenesis COVID-19. Objective: To evaluate whether levels can predict short-term clinical outcomes identify viral factors associated hospitalized SARS-CoV-2. Design: Cross-sectional study baseline level from 2540 participants enrolled TICO (Therapeutics for Inpatients With COVID-19) platform trial August 2020 to November 2021,...

10.7326/m22-0924 article EN Annals of Internal Medicine 2022-08-29

In the Strategic Timing of Antiretroviral Treatment (START) study, immediate combination antiretroviral therapy (cART) initiation reduced cancer risk by 64%. We hypothesized that reduction was higher for infection-related and determined differences in CD4 cell counts human immunodeficiency virus (HIV) RNA between study arms. Incident malignancies START were categorized into infection-unrelated cancer. used Cox models to assess factors associated with both categories. sequential adjustment...

10.1093/cid/ciw621 article EN Clinical Infectious Diseases 2016-09-08

Future strategies aiming to achieve HIV-1 remission are likely target individuals with small reservoir size.We retrospectively investigated factors associated DNA levels in European, perinatally HIV-infected children starting antiretroviral therapy (ART) <6 months of age.Total was measured from 51 long-term suppressed aged 6.3 years (median) after initial viral suppression. Factors log10 total were analyzed using linear regression.At ART initiation, median [IQR] 2.3 [1.2-4.1] months, CD4% 37...

10.1097/qai.0000000000001789 article EN cc-by-nc JAIDS Journal of Acquired Immune Deficiency Syndromes 2018-06-28
Anna Turkova Hylke Waalewijn Man K. Chan Pauline Bollen Mutsa Bwakura‐Dangarembizi and 95 more Adeodata Kekitiinwa Mark F. Cotton Abbas Lugemwa Ebrahim Variava Grace Miriam Ahimbisibwe Ussanee Srirompotong Vivian Mumbiro Pauline Amuge Peter Zuidewind Shabinah S. Ali Cissy Kityo Moherndran Archary Rashida A. Ferrand Avy Violari Diana M. Gibb David M. Burger Deborah Ford Angela Colbers Amina Farhana Mehar Pattamukkil Abraham Elaine J. Abrams Judith Acero Gerald Muzorah Agaba Grace Miriam Ahimbisibwe Barbara Ainebyoona Winnie Akobye Yasmeen Akhalwaya Nazim Akoojee Shabinah S. Ali Pauline Amuge Catherine Andrea María Ángeles Muñoz‐Fernández Rogers Ankunda Diana Antonia Rutebarika Suvaporn Anugulruengkitt Tsitsi Apollo Moherndran Archary Ronelle Arendze Juliet Ategeka Eunice Atim Lorna Atwine Abdel G. Babiker Sarah Babirye Enock Babu Edward Bagirigomwa Angella Baita David Balamusani Patsy Baliram David Baliruno Colin Ball Henry Balwa Alasdair Bamford Srini Bandi Dominique Barker Linda Barlow‐Mosha Dickson Bbuye Shazia Begum Osee Behuhuma Sarah Bernays Rogers Besigye Maria Bester Joyline Bhiri Davide Bilardi Kristien Bird Pauline Bollen Chiara Borg Anne-Marie Borges Da Silva Jackie Brown Elena Bruno Torsak Bunupuradah David M. Burger Nomzamo Buthelezi Mutsa Bwakura‐Dangarembizi Africanus Byaruhanga J. Calvert Petronelle Casey Haseena Cassim Sphiwee Cebekhulu Sanuphong Chailert Suwalai Chalermpantmetagul Wanna Chamjamrat Man K. Chan Precious Chandiwana Thannapat Chankun Sararut Chanthaburanun Nuttawut Chanto Ennie Chidziva Minenhle Chikowore Joy Chimanzi Dujrudee Chinwong Stuart Chitongo Moses Chitsamatanga Joshua Choga Duangrat Chutima Polly Clayden

BackgroundChildren with HIV-associated tuberculosis (TB) have few antiretroviral therapy (ART) options. We aimed to evaluate the safety and pharmacokinetics of dolutegravir twice-daily dosing in children receiving rifampicin for TB.MethodsWe nested a two-period, fixed-order pharmacokinetic substudy within open-label, multicentre, randomised, controlled, non-inferiority ODYSSEY trial at research centres South Africa, Uganda, Zimbabwe. Children (aged 4 weeks <18 years) TB who were eligible...

10.1016/s2352-3018(22)00160-6 article EN cc-by The Lancet HIV 2022-07-19
Christina E. Barkauskas Eleftherios Mylonakis Garyphallia Poulakou Barnaby Edward Young David M. Vock and 95 more Lianne Siegel Nicole Engen Greg Grandits Nilima Mosaly Andrew M. Vekstein Ralph Rogers Fadi Shehadeh Matthew Kaczynski Evangelia K. Mylona Konstantinos N. Syrigos Vasiliki Rapti David Chien Lye Diong Shiau Hui Lindsay Leither Kirk U. Knowlton Mamta K. Jain Rubria Marines‐Price Alice Osuji J. Scott Overcash Ioannis Kalomenidis Zafeiria Barmparessou Michael R. Waters Karla Zepeda Peter Chen Sam Torbati Francis Kiweewa Nicholus Sebudde Eyad Almasri Alyssa Hughes Sanjay Bhagani Alison Rodger Uriel Sandkovsky Robert Gottlieb Nnakelu Eriobu Barbara W. Trautner Vidya Menon Joseph Lutaakome Michael A. Matthay Philip A. Robinson Konstantinos Protopapas Νikolaos Koulouris Ivan Kimuli Amiran Baduashvili Dominique L. Braun Huldrych F. Günthard Srikanth Ramachandruni Robert Kidega Kami Kim Timothy Hatlen Andrew Phillips Daniel D. Murray Tomas Ø. Jensen María L. Padilla Evan Accardi Kathryn Shaw‐Saliba Robin Dewar Marc Teitelbaum Ven Natarajan Sylvain Laverdure Helene C. Highbarger M. Tauseef Rehman Susan Vogel David Vallée Page Crew Negin Atri Adam Schechner Sarah Pett Fleur Hudson Jonathan Badrock Giota Touloumi Samuel M. Brown Wesley H. Self Crystal M. North Adit A. Ginde Christina C. Chang Anthony D. Kelleher Stephanie Nagy-Agren Shikha Vasudeva David P. Looney Hien Nguyen Adriana Sánchez Amy Weintrob Birgit Grund Shweta Sharma Cavan Reilly Roger Paredes Agnieszka Bednarska Norman P. Gerry Abdel G. Babiker Victoria J. Davey Annetine C. Gelijns Elizabeth S. Higgs Virginia L. Kan Gail Matthews B. Taylor Thompson

Ensovibep (MP0420) is a designed ankyrin repeat protein, novel class of engineered proteins, under investigation as treatment SARS-CoV-2 infection.To investigate if ensovibep, in addition to remdesivir and other standard care, improves clinical outcomes among patients hospitalized with COVID-19 compared care alone.Double-blind, randomized, placebo-controlled, trial. (ClinicalTrials.gov: NCT04501978).Multinational, multicenter trial.Adults COVID-19.Intravenous 600 mg, or placebo.Ensovibep was...

10.7326/m22-1503 article EN Annals of Internal Medicine 2022-08-08

For people with HIV and CD4+ counts >500 cells/mm3, early initiation of antiretroviral therapy (ART) reduces serious AIDS non-AIDS (SNA) risk compared deferral treatment until are <350 cells/mm3. Whether excess SNA persists once ART is initiated for those who defer uncertain.The Strategic Timing AntiRetroviral Treatment (START) trial, as previously reported, randomly assigned 4684 ART-naive HIV-positive adults .500 cells/mm3 to immediate after random assignment (n = 2325) or deferred (n=...

10.1056/evidoa2200302 article EN NEJM Evidence 2023-02-27

Background/aims Safe and effective therapies for COVID-19 are urgently needed. In order to meet this need, the Accelerating Therapeutic Interventions Vaccines public–private partnership initiated Therapeutics Inpatients with COVID-19. is a multi-arm, multi-stage platform master protocol, which facilitates rapid evaluation of safety efficacy novel candidate antiviral therapeutic agents adults hospitalized Five have so far entered answers already provided three these. Other expected enter...

10.1177/17407745211049829 article EN other-oa Clinical Trials 2021-10-10
Samuel M. Brown Christina E. Barkauskas Birgit Grund Shweta Sharma Andrew Phillips and 95 more Lindsay Leither Ithan D. Peltan Michael J. Lanspa Daniel L Gilstrap Ahmad Mourad Kathleen Lane Jeremy R. Beitler Alexis Serra Ivan Garcia Eyad Almasri Mohamed Fayed Kinsley Hubel Estelle S. Harris Elizabeth A. Middleton Macy A G Barrios Kusum S. Mathews Neha Goel Samuel Acquah Jarrod Mosier Cameron Hypes Elizabeth Salvagio Campbell Akram Khan Catherine L. Hough Jennifer G. Wilson Joseph E. Levitt Abhijit Duggal Siddharth Dugar Andrew J. Goodwin Charles R. Terry Peter Chen Sam Torbati Nithya Iyer Uriel Sandkovsky Nicholas J. Johnson Bryce R. H. Robinson Michael A. Matthay Neil R. Aggarwal Ivor S. Douglas Jonathan D. Casey Manuel Hache-Marliere J.G. Youssef William Nkemdirim Brad Leshnower Omar Awan Sonal Pannu D. Shane O’Mahony Prasad Manian J.W. Awori Hayanga Glenn Wortmann Bruno Martins Tomazini Robert F. Miller Jens‐Ulrik Stæhr Jensen Daniel D. Murray Nina A. Bickell Jigna Zatakia Sarah Burris Elizabeth S. Higgs Ven Natarajan Robin Dewar Adam Schechner Nayon Kang Alejandro Arenas‐Pinto Fleur Hudson Adit A. Ginde Wesley H. Self Angela J. Rogers Cathryn F. Oldmixon Haley Morin Adriana Sánchez Amy Weintrob Alexandre Biasi Cavalcanti Anne Davis‐Karim Nicole Engen Eileen Denning Bruce Thompson Annetine C. Gelijns Virginia L. Kan Victoria J. Davey Jens Lundgren Abdel G. Babiker James D. Neaton H. Clifford Lane John Tierney Susan Vogel Laura A. McNay Kelly Cahill Page Crew Ratna Sardana Sharo Segal Raim Kathryn Shaw‐Saliba Negin Atri Mark D. Miller David Vallée Lucy Chung Yvette Delph

10.1016/s2213-2600(23)00147-9 article EN publisher-specific-oa The Lancet Respiratory Medicine 2023-06-19
Alexandra Compagnucci Man K. Chan Yacine Saïdi Tim R. Cressey Alasdair Bamford and 95 more Yoann Riault Alexandra Coelho Aoife Nolan Suwalai Chalermpantmetagul Gabija Morkunaite Pauline Amuge Victor Musiime Avy Violari Mark F. Cotton Adeodata Kekitiinwa Elizabeth Kaudha Marisa Groenewald Afaaf Liberty Suparat Kanjanavanit Алла Волоха Rosa Bologna Noris Pavia Ruz Luis Prieto P Paioni Lino Marques Véronique Reliquet Tim Niehues Steven B. Welch Deborah Ford Carlo Giaquinto Diana M. Gibb Abdel G. Babiker José Tomás Ramos-Amador Alexandra Compagnucci Y Saïdi Yoann Riault André Coelho Claude Kouakam Loïc Picault Moustapha Ndiaye Laurence Meyer Carole Cagnot Sophie Circosta L Léger S. Simanic A. Arulananthan Diana M. Gibb Abdel G. Babiker Mei Yen Chan Deborah Ford Fleur Hudson Lynda Harper Alasdair Bamford Anna Nolan Kaja Widuch S. Townsend N. Van-Looy Li Gao E. Little Anna Turkova Stella M. Fabiane J. Calvert James Blackstone Karen Scott Jamie Inshaw Andrew Nunn Anthony Nardone Davide Bilardi Tim R. Cressey Suwalai Chalermpantmetagul Woottichai Khamduang Gonzague Jourdain Nicole Ngo Giang Huong Dujrudee Chinwong Chalermpong Saenjum Rukchanok Peongjakta Pra-ornsuda Sukrakanchana Laddawan Laomanit Ampika Kaewbundit Jiraporn Khamkon Kanchana Than-in-at C. Meeboon Worathip Sripaoraya Nitinart Krueduangkam Namthip Kruenual Warunee Khamjakkaew Soraya Klinprung Carlo Giaquinto Gabija Morkunaite Déborah Hirt Luis Prieto Tim Niehues Dietmar Plonné Constanza Morén Telma Noguera María Ángeles Muñoz‐Fernández Rosa Bologna Solange Arazi A.G. Fedullo Moira Taicz

BackgroundIntegrase inhibitor (INSTI) with boosted darunavir (DRV/r), a regimen high-resistance barrier, avoiding NRTI toxicities, might be switching option in children living HIV (CLWHIV).MethodsSMILE is randomised non-inferiority trial evaluating safety and antiviral efficacy of once-daily INSTI + DRV/r vs. continuing on current standard-of-care (SOC) triple ART (2NRTI PI/NNRTI) virologically-suppressed CLWHIV aged 6–18 years. The primary outcome the proportion confirmed HIV-RNA ≥50...

10.1016/j.eclinm.2023.102025 article EN cc-by-nc-nd EClinicalMedicine 2023-06-01

Many cohort studies and clinical trials have designs which involve repeated measurements of disease markers. One problem in such longitudinal studies, when the primary interest is to estimate compare evolution a marker, that planned data are not collected because missing due visits and/or withdrawal or attrition (for example, death). Several methods analyse available, provided at random. However, serious biases can occur ness informative. In cases, one needs apply simultaneously model...

10.1002/(sici)1097-0258(19990530)18:10<1215::aid-sim118>3.0.co;2-6 article EN Statistics in Medicine 1999-05-30

Many cohort studies and clinical trials use repeated measurements of laboratory markers to track disease progression evaluate new therapies. A major problem in the analysis such is that marker data are censored some patients owing withdrawal, loss follow-up, or death. The objective this paper impact selective dropouts attributable death on estimates change among different groups.Data CD4 cell count human immunodeficiency virus 1-infected individuals from a trial study used illustrate...

10.1097/00001648-200205000-00017 article EN Epidemiology 2002-05-01

Non-inferiority trials are increasingly used to evaluate new treatments that expected have secondary advantages over standard of care, but similar efficacy on the primary outcome. When designing a non-inferiority trial with binary outcome, choice effect measure for margin (e.g. risk ratio or difference) has an important sample size calculations; furthermore, if control event observed is markedly different from assumed, can quickly lose power results become difficult interpret.We propose way...

10.1186/s13063-020-4070-4 article EN cc-by Trials 2020-02-06

Abstract Many cohort studies and clinical trials are designed to compare rates of change over time in one or more disease markers several groups. One major problem such longitudinal is missing data due patient drop‐out. The bias efficiency six different methods estimate changes with incomplete observations were compared: generalized estimating equation estimates (GEE) proposed by Liang Zeger (1986); unweighted average ordinary least squares (OLSE) individual (UWLS); weighted OLSE (WLS);...

10.1002/sim.1114 article EN Statistics in Medicine 2001-12-20
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