Publications by authors named "Michael D Hughes"

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Evaluating Treatment Effects with Patient-Response-Related Outcomes in Comparative Clinical Trials.
Lu Mao, Lu Tian, Bo Huang, Paul G Richardson, Ethan B Ludmir, Michael D Hughes

NEJM Evid· December 2025

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Virological and drug-resistance outcomes for people living with HIV initiating or switching to tenofovir, lamivudine, and dolutegravir in six PEPFAR-supported countries: a prospective cohort study.
Jean Bernard Marc, Caitlyn McCarthy, Carole L Wallis, Cissy Kityo, Michael D Hughes

Lancet HIV· December 2025

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Protecting households on exposure to newly diagnosed index multidrug-resistant tuberculosis patients: Study protocol for the PHOENIx phase 3 clinical trial.
Michelle A Kendall, Michael D Hughes, Soyeon Kim, Lisa A Aaron, Linda Naini

Contemp Clin Trials· November 2025

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Precision medicine evaluation of heterogeneity of treatment effect for a time-to-event outcome with application in a trial of Initial treatment for people living with HIV.
Yu Zheng, Judy S Currier, Michael D Hughes

Clin Trials· October 2025

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Long-term clinical, immunologic, and viral reservoir outcomes in children treated with VRC01LS and 10-1074 monoclonal antibodies in the Tatelo Study.
Gbolahan Ajibola, Bryan S Nelson, Aischa Niesar, Seohyun Hong, Melanie Lancien, Michael D Hughes

Clin Infect Dis· October 2025

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Rapid Elimination of Culturable SARS-CoV-2 With Intramuscular or Intravenous Administration of Antiviral Monoclonal Antibody Therapy.
Rinki Deo, Manish C Choudhary, Owen T Glover, Rachel Bender Ignacio, Julie Boucau, Michael D Hughes

Open Forum Infect Dis· September 2025

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Evaluating viral load sampling schemes and swabbing methods for optimal surrogacy.
Allyson Mateja, Eric Chu, Thomas A Murray, Carolyn T Bramante, Carlee Moser, Michael D Hughes

J Infect Dis· August 2025

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Ensitrelvir for the Treatment of Nonhospitalized Adults with COVID-19: Results from the SCORPIO-HR, Phase 3, Randomized, Double-blind, Placebo-Controlled Trial.
Anne F Luetkemeyer, Kara W Chew, Stuart Lacey, Michael D Hughes, Linda J Harrison

Clin Infect Dis· July 2025

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The Choice of Viral Load End Point in Early Phase Trials of COVID-19 Treatments Aiming to Reduce 28-Day Hospitalization and/or Death.
Allyson Mateja, Eric Chu, Thomas A Murray, Carolyn T Bramante, Carlee Moser, Michael D Hughes

J Infect Dis· July 2025

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Virology Outcomes of Tenofovir-lamivudine-dolutegravir in Treatment-naïve and Virologically Suppressed Individuals Switching From an NNRTI-based Regimen: An Observational Analysis at 13 Sites.
Cissy Kityo, Caitlyn McCarthy, Serena P Koenig, Michael D Hughes, Carole L Wallis

Open Forum Infect Dis· July 2025

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Implementation of a seamless phase 2/3 study design in the setting of an emergent infectious disease pandemic: Lessons learned from the ACTIV-2 platform COVID-19 treatment trial.
Mark J Giganti, Kara W Chew, Carlee Moser, Joseph J Eron, Mauricio Pinilla, Michael D Hughes

Contemp Clin Trials· June 2025

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Tixagevimab/cilgavimab or placebo for COVID-19 in ACTIV-2: Safety, pharmacokinetics and neutralizing and anti-drug antibodies.
Rachel A Bender Ignacio, Kara W Chew, Carlee Moser, Judith S Currier, Joseph J Eron, Michael D Hughes

iScience· March 2025

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Predictive markers for sustained viral suppression on dual bNAbs during ART interruption in children.
Jaspreet Banga, Bryan S Nelson, Gbolahan Ajibola, Terence Mohammed, Comfort Maphorisa, Michael D Hughes

J Acquir Immune Defic Syndr· March 2025

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Viral and Symptom Rebound Following Anti-Severe Acute Respiratory Syndrome Coronavirus 2 Monoclonal Antibody Therapy in a Randomized Placebo-Controlled Trial.
Kara W Chew, Brooke McGinley, Carlee Moser, Jonathan Z Li, Teresa H Evering, Michael D Hughes

J Infect Dis· February 2025

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Early antiviral CD4+ and CD8+ T cells are associated with upper airway clearance of SARS-CoV-2.
Sydney I Ramirez, Paul G Lopez, Farhoud Faraji, Urvi M Parikh, Amy Heaps, Michael D Hughes

JCI Insight· December 2024

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Safety and Efficacy of SAB-185 for Nonhospitalized Adults With COVID-19: A Randomized Clinical Trial.
Kara W Chew, Babafemi O Taiwo, Carlee Moser, Eric S Daar, David Alain Wohl, Michael D Hughes

J Infect Dis· November 2024

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SARS-CoV-2 Monoclonal Antibody Treatment Followed by Vaccination Shifts Human Memory B-Cell Epitope Recognition, Suggesting Antibody Feedback.
Nathaniel Bloom, Sydney I Ramirez, Hallie Cohn, Urvi M Parikh, Amy Heaps, Michael D Hughes

J Infect Dis· November 2024

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Mortality and Associated Risk Factors Among People Living With HIV With Kaposi Sarcoma: A5263/AMC066 and A5264/AMC067.
Maganizo B Chagomerana, Carlee B Moser, Minhee Kang, Triin Umbleja, Michael D Hughes

J Acquir Immune Defic Syndr· November 2024

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SARS-CoV-2 Plasma Antibody and Nucleocapsid Antigen Status Predict Outcomes in Outpatients With COVID-19.
Nikolaus Jilg, Mark J Giganti, Kara W Chew, Katy Shaw-Saliba, Justin Ritz, Michael D Hughes

Clin Infect Dis· October 2024

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ACTIV trials: Lessons learned in trial design in the setting of an emergent pandemic.
Maryam Keshtkar-Jahromi, Kevin J Anstrom, Christina Barkauskas, Samuel M Brown, Eric S Daar, Michael D Hughes

J Clin Transl Sci· October 2024

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The statistical design and analysis of pandemic platform trials: Implications for the future.
Christopher J Lindsell, Matthew Shotwell, Kevin J Anstrom, Scott Berry, Erica Brittain, Michael D Hughes

J Clin Transl Sci· October 2024

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Erratum: The statistical design and analysis of pandemic platform trials: Implications for the future - CORRIGENDUM.
Christopher J Lindsell, Matthew Shotwell, Kevin J Anstrom, Scott Berry, Erica Brittain, Michael D Hughes

J Clin Transl Sci· October 2024

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Post-acute COVID-19 outcomes including participant-reported long COVID: amubarvimab/romlusevimab versus placebo in the ACTIV-2 trial.
Teresa H Evering, Carlee Moser, Nikolaus Jilg, Justin Ritz, David A Wohl, Michael D Hughes

EClinicalMedicine· September 2024

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Susceptibility of pESI positive Salmonella to treatment with biocide chemicals approved for use in poultry meat processing as compared to Salmonella without the pESI plasmid.
Elizabeth A McMillan, Eric S Adams, Trevor R Mitchell, Jaci A Hawkins, Quentin D Read, Michael D Hughes

Lett Appl Microbiol· July 2024

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Safety, Efficacy, and Pharmacokinetics of Combination SARS-CoV-2 Neutralizing Monoclonal Antibodies BMS-986414 (C135-LS) and BMS-986413 (C144-LS) Administered Subcutaneously in Non-Hospitalized Persons with COVID-19 in a Phase 2 Trial.
Katya C Corado, Kara W Chew, Mark J Giganti, Ying Mu, Courtney V Fletcher, Michael D Hughes

Pathog Immun· May 2024

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