Abstract

The primary aims of the study are to evaluate the safety and tolerability of single and multi-doses of a mixture of two intravenous (IV) monoclonal antibodies (mAbs) in subjects with compensated, chronic Hepatitis B (HBV) infection, to obtain pharmacokinetic data of single and multi-doses of a mixture of two IV mAbs (HBV-AbXTL17 and HBV-AbXTL19, hereafter referred to as HBV-AbXTLs), and to evaluate the antiviral effect of these HBV-AbXTLs by measuring changes in the serum levels of HBV DNA and HbsAb after treatment. The two mAbs developed and produced XTL Biopharmaceuticals are fully human IgG1 antibodies directed against HbsAg. Theoretically, combination therapy using a mixture of two different mAbs directed to different antigenic targets may reduce the production of viral escape mutants and the frequency of treatment failure. The UCSF GCRC will be utilized to insure reliable pharmacokinetic samples are obtained along with proper IV administration of the study medication. Accurate record keeping will also be assured by the GCRC staff.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
2M01RR000079-37A1
Application #
6407582
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
1974-12-01
Project End
2003-11-30
Budget Start
Budget End
Support Year
37
Fiscal Year
2000
Total Cost
Indirect Cost

  Institution

Name
University of California San Francisco
Department
Type
DUNS #
073133571
City
San Francisco
State
CA
Country
United States
Zip Code
94143

  Publications

Kurtz, Theodore W; DiCarlo, Stephen E; Pravenec, Michal et al. (2018) Functional foods for augmenting nitric oxide activity and reducing the risk for salt-induced hypertension and cardiovascular disease in Japan. J Cardiol 72:42-49
Anderegg, Nanina; Johnson, Leigh F; Zaniewski, Elizabeth et al. (2017) All-cause mortality in HIV-positive adults starting combination antiretroviral therapy: correcting for loss to follow-up. AIDS 31 Suppl 1:S31-S40
Morris Jr, R Curtis; Schmidlin, Olga; Sebastian, Anthony et al. (2016) Vasodysfunction That Involves Renal Vasodysfunction, Not Abnormally Increased Renal Retention of Sodium, Accounts for the Initiation of Salt-Induced Hypertension. Circulation 133:881-93
Kurtz, Theodore W; DiCarlo, Stephen E; Pravenec, Michal et al. (2016) An alternative hypothesis to the widely held view that renal excretion of sodium accounts for resistance to salt-induced hypertension. Kidney Int 90:965-973
Kurtz, Theodore W; DiCarlo, Stephen E; Morris Jr, R Curtis (2016) Logical Issues With the Pressure Natriuresis Theory of Chronic Hypertension. Am J Hypertens 29:1325-1331
Cruz, Giovanna I; Shao, Xiaorong; Quach, Hong et al. (2016) A Child's HLA-DRB1 genotype increases maternal risk of systemic lupus erythematosus. J Autoimmun 74:201-207
Brambati, Simona Maria; Amici, Serena; Racine, Caroline A et al. (2015) Longitudinal gray matter contraction in three variants of primary progressive aphasia: A tenser-based morphometry study. Neuroimage Clin 8:345-55
Abraham, Alison G; Althoff, Keri N; Jing, Yuezhou et al. (2015) End-stage renal disease among HIV-infected adults in North America. Clin Infect Dis 60:941-9
Wang, Julie B; Pierce, John P; Ayala, Guadalupe X et al. (2015) Baseline Depressive Symptoms, Completion of Study Assessments, and Behavior Change in a Long-Term Dietary Intervention Among Breast Cancer Survivors. Ann Behav Med 49:819-27
Brehm, John M; Ramratnam, Sima K; Tse, Sze Man et al. (2015) Stress and Bronchodilator Response in Children with Asthma. Am J Respir Crit Care Med 192:47-56

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