A passive immunotherapy, (PE)HRG214, in patients infected with human immunodeficiency virus: a phase I study.
(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.
Dezube
Bruce J
BJ
Division of Hematology/Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA. bdezube@caregroup.harvard.edu
Proper
JoAnn
J
Zhang
Jielin
J
Choy
Vern J
VJ
Weeden
William
W
Morrissey
Janine
J
Burns
Eve M
EM
Dixon
James D
JD
O'Loughlin
Christopher
C
Williams
Lisa A
LA
Pickering
Paul J
PJ
Crumpacker
Clyde S
CS
Gelder
Frank B
FB
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
D000914:Antibodies, Viral; D007106:Immune Sera; D007074:Immunoglobulin G; D012367:RNA, Viral