A phase I trial with two human monoclonal antibodies (hMAb 2F5, 2G12) against HIV-1

AIDS
Christine ArmbrusterHermann Katinger

Abstract

To study the safety, immunogenicity and pharmacokinetics of two intravenously administered human monoclonal antibodies (hMAb 2F5, 2G12) against HIV-1 in humans. Open label clinical phase I trial. Primary institutional care. Seven HIV-1-infected healthy volunteers with > or = 500 x 10(6)CD4 cells/l and < or = 10,000 HIV-1 RNA copies/ml, not treated with highly active antiretroviral therapy (HAART), entered and finished the study. and main outcome measures: Eight separate infusions of the hMAb were administered over a 4-week period (total dose 14 g). The safety was assessed by physical examination, blood chemistry, complete blood cell count and recording adverse events. 2F5 and 2G12 plasma levels were determined prior to and at the end of each infusion and during the follow-up period of 22 weeks. No clinical or laboratory abnormalities were observed throughout the study. The median distribution half-life (t(1/2 alpha)) of 2F5 and 2G12 was 1.02 (range, 0.77-1.47) days and 2.49 (range, 0.92-4.59) days, respectively. The elimination half-life (t(1/2 beta)) was calculated to be 7.94 (range, 3.46-8.31) days for 2F5 and 16.48 (range, 12.84-24.85) days for 2G12. The median plasma concentration immediately after the first infusion was 21...Continue Reading

Associated Clinical Trials

References

Jan 10, 1995·Virology·Q J SattentauP Poignard
Dec 1, 1994·AIDS Research and Human Retroviruses·M PurtscherA Jungbauer
Aug 1, 1993·The Journal of Infectious Diseases·J M JacobsonA M Prince
Jun 1, 1996·Clinical Pharmacology and Therapeutics·E J WolfeJ G Gambertoglio
Jun 24, 1998·Journal of Acquired Immune Deficiency Syndromes and Human Retrovirology : Official Publication of the International Retrovirology Association·T R O'BrienJ J Goedert
Jul 11, 2000·Nature Medicine·D D Ho, L Zhang

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Citations

Feb 8, 2007·Transgenic Research·Penelope Amelia Claire SparrowJulian K C Ma
Jun 14, 2005·Immunology Letters·Xiao-Nan DongYing-Hua Chen
Jun 29, 2002·Current Opinion in Immunology·Flavia Ferrantelli, Ruth M Ruprecht
Apr 19, 2005·Nature Biotechnology·Jianmin FangKarin Jooss
Nov 1, 2007·Journal of Applied Animal Welfare Science : JAAWS·Andrew Knight
Aug 11, 2011·AIDS Research and Human Retroviruses·Weizao Chen, Dimiter S Dimitrov
Apr 3, 2009·Current Opinion in HIV and AIDS·Weizao Chen, Dimiter S Dimitrov
Nov 18, 2009·Current Opinion in Infectious Diseases·Georgina C Morris, Charles J N Lacey
Nov 2, 2012·Clinical and Vaccine Immunology : CVI·Vincent J VendittoFrancis C Szoka
Jan 8, 2013·BMC Medicine·Michela FlegoStefano Vella
Dec 29, 2010·PLoS Pathogens·Xin M LuoDavid Baltimore
Apr 3, 2012·BioDrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy·Rui GongDimiter S Dimitrov
Apr 20, 2014·BioMed Research International·Matilde MerlinLinda Avesani
May 7, 2014·Immunology and Cell Biology·Wendy R WinnallStephen J Kent
May 24, 2014·Journal of Acquired Immune Deficiency Syndromes : JAIDS·Ming SunDavid D Ho
Jan 15, 2004·Journal of Acquired Immune Deficiency Syndromes : JAIDS·Jeffrey T SafritUNKNOWN Ghent IAS Working Group on HIV in Women Children
Jul 20, 2005·Expert Review of Vaccines·Aldar S Bourinbaiar, Rivka Abulafia-Lapid
Aug 2, 2002·Expert Opinion on Investigational Drugs·Christine Armbruster
Dec 13, 2006·Expert Opinion on Investigational Drugs·Paola Citterio, Stefano Rusconi
Oct 2, 2003·Expert Opinion on Biological Therapy·L H Stockwin, S Holmes
Mar 10, 2004·Expert Opinion on Biological Therapy·Maja A SommerfeltBirger Sørensen
Feb 24, 2009·Annals of Medicine·Haritha SamaranayakeSeppo Ylä-Herttuala
Feb 5, 2016·Current HIV/AIDS Reports·Kathryn E Stephenson, Dan H Barouch
Nov 9, 2010·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Ryan J MorrowR Karl Malcolm
Dec 25, 2015·Science Translational Medicine·Rebecca M LynchUNKNOWN VRC 601 Study Team
Dec 24, 2005·Enfermedades infecciosas y microbiología clínica·Felipe GarcíaPere Domingo

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