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HIV prevention trial design in an era of effective pre-exposure prophylaxis.
Cutrell A, Donnell D, Dunn DT, Glidden DV, Grobler A, Hanscom B, Stancil BS, Meyer RD, Wang R, Cuffe RL. Cutrell A, et al. Among authors: donnell d. HIV Clin Trials. 2017 Nov-Dec;18(5-6):177-188. doi: 10.1080/15284336.2017.1379676. Epub 2017 Oct 17. HIV Clin Trials. 2017. PMID: 29039265 Free PMC article. Review.
Assessing Durability of Vaccine Effect Following Blinded Crossover in COVID-19 Vaccine Efficacy Trials.
Follmann D, Fintzi J, Fay MP, Janes HE, Baden L, Sahly HE, Fleming TR, Mehrotra DV, Carpp LN, Juraska M, Benkeser D, Donnell D, Fong Y, Han S, Hirsch I, Huang Y, Huang Y, Hyrien O, Luedtke A, Carone M, Nason M, Vandebosch A, Zhou H, Cho I, Gabriel E, Kublin JG, Cohen MS, Corey L, Gilbert PB, Neuzil KM. Follmann D, et al. Among authors: donnell d. medRxiv [Preprint]. 2020 Dec 14:2020.12.14.20248137. doi: 10.1101/2020.12.14.20248137. medRxiv. 2020. PMID: 33336213 Free PMC article. Updated. Preprint.
Facilitating Next-Generation Pre-Exposure Prophylaxis Clinical Trials Using HIV Recent Infection Assays: A Consensus Statement from the Forum HIV Prevention Trial Design Project.
Parkin N, Gao F, Grebe E, Cutrell A, Das M, Donnell D, Duerr A, Glidden DV, Hughes JP, Murray J, Robertson MN, Zinserling J, Lau J, Miller V; Forum for Collaborative Research Recency Assay Working Group. Parkin N, et al. Among authors: donnell d. Clin Pharmacol Ther. 2023 Jul;114(1):29-40. doi: 10.1002/cpt.2830. Epub 2023 Jan 5. Clin Pharmacol Ther. 2023. PMID: 36550769 Review.
Clinical Endpoints for Evaluating Efficacy in COVID-19 Vaccine Trials.
Mehrotra DV, Janes HE, Fleming TR, Annunziato PW, Neuzil KM, Carpp LN, Benkeser D, Brown ER, Carone M, Cho I, Donnell D, Fay MP, Fong Y, Han S, Hirsch I, Huang Y, Huang Y, Hyrien O, Juraska M, Luedtke A, Nason M, Vandebosch A, Zhou H, Cohen MS, Corey L, Hartzel J, Follmann D, Gilbert PB. Mehrotra DV, et al. Among authors: donnell d. Ann Intern Med. 2021 Feb;174(2):221-228. doi: 10.7326/M20-6169. Epub 2020 Oct 22. Ann Intern Med. 2021. PMID: 33090877 Free PMC article.
A Deferred-Vaccination Design to Assess Durability of COVID-19 Vaccine Effect After the Placebo Group Is Vaccinated.
Follmann D, Fintzi J, Fay MP, Janes HE, Baden LR, El Sahly HM, Fleming TR, Mehrotra DV, Carpp LN, Juraska M, Benkeser D, Donnell D, Fong Y, Han S, Hirsch I, Huang Y, Huang Y, Hyrien O, Luedtke A, Carone M, Nason M, Vandebosch A, Zhou H, Cho I, Gabriel E, Kublin JG, Cohen MS, Corey L, Gilbert PB, Neuzil KM. Follmann D, et al. Among authors: donnell d. Ann Intern Med. 2021 Aug;174(8):1118-1125. doi: 10.7326/M20-8149. Epub 2021 Apr 13. Ann Intern Med. 2021. PMID: 33844575 Free PMC article.
Adults on pre-exposure prophylaxis (tenofovir-emtricitabine) have faster clearance of anti-HIV monoclonal antibody VRC01.
Huang Y, Zhang L, Karuna S, Andrew P, Juraska M, Weiner JA, Angier H, Morgan E, Azzam Y, Swann E, Edupuganti S, Mgodi NM, Ackerman ME, Donnell D, Gama L, Anderson PL, Koup RA, Hural J, Cohen MS, Corey L, McElrath MJ, Gilbert PB, Lemos MP. Huang Y, et al. Among authors: donnell d. Nat Commun. 2023 Nov 28;14(1):7813. doi: 10.1038/s41467-023-43399-5. Nat Commun. 2023. PMID: 38016958 Free PMC article.
321 results