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Safety, Tolerability, and Pharmacokinetics of the Broadly Neutralizing Human Immunodeficiency Virus (HIV)-1 Monoclonal Antibody VRC01 in HIV-Exposed Newborn Infants.
Cunningham CK, McFarland EJ, Morrison RL, Capparelli EV, Safrit JT, Mofenson LM, Mathieson B, Valentine ME, Perlowski C, Smith B, Hazra R, Purdue L, Muresan P, Harding PA, Mbengeranwa T, Robinson LG, Wiznia A, Theron G, Lin B, Bailer RT, Mascola JR, Graham BS; IMPAACT P1112 team. Cunningham CK, et al. Among authors: smith b. J Infect Dis. 2020 Jul 23;222(4):628-636. doi: 10.1093/infdis/jiz532. J Infect Dis. 2020. PMID: 31681963 Free PMC article. Clinical Trial.
Safety, Tolerability, and Pharmacokinetics of a Long-Acting Broadly Neutralizing Human Immunodeficiency Virus Type 1 (HIV-1) Monoclonal Antibody VRC01LS in HIV-1-Exposed Newborn Infants.
McFarland EJ, Cunningham CK, Muresan P, Capparelli EV, Perlowski C, Morgan P, Smith B, Hazra R, Purdue L, Harding PA, Theron G, Mujuru H, Agwu A, Purswani M, Rathore MH, Flach B, Taylor A, Lin BC, McDermott AB, Mascola JR, Graham BS; International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT) P1112 Team. McFarland EJ, et al. Among authors: smith b. J Infect Dis. 2021 Dec 1;224(11):1916-1924. doi: 10.1093/infdis/jiab229. J Infect Dis. 2021. PMID: 34009371 Free PMC article.
Pharmacokinetics and tolerance of zidovudine in preterm infants.
Capparelli EV, Mirochnick M, Dankner WM, Blanchard S, Mofenson L, McSherry GD, Gay H, Ciupak G, Smith B, Connor JD; Pediatric AIDS Clinical Trials Group 331 Investigators. Capparelli EV, et al. Among authors: smith b. J Pediatr. 2003 Jan;142(1):47-52. doi: 10.1067/mpd.2003.mpd0335. J Pediatr. 2003. PMID: 12520254 Clinical Trial.
Clinical response and tolerability to and safety of saquinavir with low-dose ritonavir in human immunodeficiency virus type 1-infected mothers and their infants.
Zorrilla CD, Van Dyke R, Bardeguez A, Acosta EP, Smith B, Hughes MD, Huang S, Watts DH, Heckman B, Jiménez E, McSherry G, Mofenson L. Zorrilla CD, et al. Among authors: smith b. Antimicrob Agents Chemother. 2007 Jun;51(6):2208-10. doi: 10.1128/AAC.00871-06. Epub 2007 Apr 9. Antimicrob Agents Chemother. 2007. PMID: 17420209 Free PMC article.
Use of Modeling and Simulations to Determine Raltegravir Dosing in Neonates: A Model for Safely and Efficiently Determining Appropriate Neonatal Dosing Regimens: IMPAACT P1110.
Clarke DF, Mirochnick M, Acosta EP, Capparelli E, Chain A, Teppler H, Smith B, Lommerse J; International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) P1110 Study Team. Clarke DF, et al. Among authors: smith b. J Acquir Immune Defic Syndr. 2019 Dec 1;82(4):392-398. doi: 10.1097/QAI.0000000000002149. J Acquir Immune Defic Syndr. 2019. PMID: 31658182 Free PMC article.
Raltegravir (RAL) in Neonates: Dosing, Pharmacokinetics (PK), and Safety in HIV-1-Exposed Neonates at Risk of Infection (IMPAACT P1110).
Clarke DF, Acosta EP, Cababasay M, Wang J, Chain A, Teppler H, Popson S, Graham B, Smith B, Hazra R, Calabrese K, Bryson Y, Spector SA, Lommerse J, Mirochnick M; IMPAACT P1110 Protocol Team. Clarke DF, et al. Among authors: smith b. J Acquir Immune Defic Syndr. 2020 May 1;84(1):70-77. doi: 10.1097/QAI.0000000000002294. J Acquir Immune Defic Syndr. 2020. PMID: 31913995 Free PMC article. Clinical Trial.
Safety and immunogenicity of early measles vaccination in children born to HIV-infected mothers in the United States: results of Pediatric AIDS Clinical Trials Group (PACTG) protocol 225.
Chandwani S, Beeler J, Li H, Audet S, Smith B, Moye J, Nalin D, Krasinski K; PACTG 225 Study Team. Chandwani S, et al. Among authors: smith b. J Infect Dis. 2011 Jul;204 Suppl 1(Suppl 1):S179-89. doi: 10.1093/infdis/jir089. J Infect Dis. 2011. PMID: 21666159 Free PMC article. Clinical Trial.
Toward Earlier Inclusion of Pregnant and Postpartum Women in Tuberculosis Drug Trials: Consensus Statements From an International Expert Panel.
Gupta A, Mathad JS, Abdel-Rahman SM, Albano JD, Botgros R, Brown V, Browning RS, Dawson L, Dooley KE, Gnanashanmugam D, Grinsztejn B, Hernandez-Diaz S, Jean-Philippe P, Kim P, Lyerly AD, Mirochnick M, Mofenson LM, Montepiedra G, Piper J, Sahin L, Savic R, Smith B, Spiegel H, Swaminathan S, Watts DH, White A. Gupta A, et al. Among authors: smith b. Clin Infect Dis. 2016 Mar 15;62(6):761-769. doi: 10.1093/cid/civ991. Epub 2015 Dec 9. Clin Infect Dis. 2016. PMID: 26658057 Free PMC article.
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