A Passive Immunotherapy,PEHRG214, in Patients Infected with Human Immunodeficiency Virus: A Phase I Study
| Autor: | Janine Morrissey, Bruce J. Dezube, James D. Dixon, William Weeden, Christopher O’Loughlin, Lisa A. Williams, Vern J. Choy, Jielin Zhang, Eve M. Burns, JoAnn Proper, Clyde S. Crumpacker, Frank B. Gelder, Paul J. Pickering |
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| Rok vydání: | 2003 |
| Předmět: |
HIV Infections
Pharmacology Antibodies Viral Immunoglobulin G Virus Antigen medicine Animals Humans Immunology and Allergy Dose-Response Relationship Drug biology business.industry Goats Immune Sera Immunization Passive Half-life biology.organism_classification Rash Virology CD4 Lymphocyte Count Dose–response relationship Infectious Diseases Lentivirus HIV-1 biology.protein RNA Viral medicine.symptom Antibody business |
| Zdroj: | The Journal of Infectious Diseases. 187:500-503 |
| ISSN: | 1537-6613 0022-1899 |
| DOI: | 10.1086/367710 |
| Popis: | (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. |
| Databáze: | OpenAIRE |
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