title: A passive immunotherapy, (PE)HRG214, in patients infected with human immunodeficiency virus: a phase I study.
abstract: (PE)HRG214 (HRG) is a polyclonal antibody preparation produced by immunization of goats with purified human immunodeficiency virus (HIV) antigens. In this phase I study, HRG was administered intravenously as a single dose (1, 2, 4, 8, or 16 mg/kg) to 18 HIV-1-infected patients with CD4 cell counts >/=50 cells/microL and virus loads >/=500 copies/mL. The most frequent adverse event was a transient rash, which appeared to be both dose- and CD4 cell count-dependent. At the 16 mg/kg level, median half-life was 68.4 h, and median C(max) was 392 microg/mL, a level well above that which inhibits HIV in vitro. At that dose level, median and maximum decreases in HIV-1 RNA levels at day 8 were 0.24 log(10) and 0.58 log(10), respectively, and, at day 29, were 0.24 log(10 ) and 2.2 log(10), respectively. HRG, administered as a single dose, is reasonably well tolerated and achieves adequate plasma concentrations.
authors.affiliation: Division of Hematology/Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA. bdezube@caregroup.harvard.edu
authors.forename: Bruce J
authors.initials: BJ
authors.lastname: Dezube
authors.forename: JoAnn
authors.initials: J
authors.lastname: Proper
authors.forename: Jielin
authors.initials: J
authors.lastname: Zhang
authors.forename: Vern J
authors.initials: VJ
authors.lastname: Choy
authors.forename: William
authors.initials: W
authors.lastname: Weeden
authors.forename: Janine
authors.initials: J
authors.lastname: Morrissey
authors.forename: Eve M
authors.initials: EM
authors.lastname: Burns
authors.forename: James D
authors.initials: JD
authors.lastname: Dixon
authors.forename: Christopher
authors.initials: C
authors.lastname: O'Loughlin
authors.forename: Lisa A
authors.initials: LA
authors.lastname: Williams
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Pickering
authors.forename: Clyde S
authors.initials: CS
authors.lastname: Crumpacker
authors.forename: Frank B
authors.initials: FB
authors.lastname: Gelder
mesh_terms: D000818:Animals; D000914:Antibodies, Viral / Q000008:administration & dosage / Q000276:immunology* / Q000627:therapeutic use*; D018791:CD4 Lymphocyte Count; D004305:Dose-Response Relationship, Drug; D006041:Goats / Q000276:immunology; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology* / Q000821:virology; D015497:HIV-1 / Q000235:genetics / Q000276:immunology; D006801:Humans; D007106:Immune Sera / Q000008:administration & dosage / Q000276:immunology; D007116:Immunization, Passive; D007074:Immunoglobulin G / Q000008:administration & dosage / Q000276:immunology; D012367:RNA, Viral / Q000032:analysis
chemical_list: D000914:Antibodies, Viral; D007106:Immune Sera; D007074:Immunoglobulin G; D012367:RNA, Viral