This trial is designed to assess the safety, tolerability, pharmacokinetics and viral kinetics after multiple infusions of bavituximab in patients co-infected with HCV and HIV.
OBJECTIVES: * To determine the safety and tolerability of bavituximab administered as multiple intravenous (IV) infusions to patients co-infected with HCV and HIV * To characterize the pharmacokinetic profile and viral kinetics after multiple intravenous infusions of bavituximab to patients infected with HCV and HIV * To define the maximum tolerated dose (MTD) and/or maximum effective dose (MED) of bavituximab administered as multiple infusions to patients infected with chronic HCV infection and HIV
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
The study drug is a sterile solution administered intravenously weekly for 8 weeks. Each cohort is given 0.3, 1, 3, or 6 mg/kg of bavituximab.
Impact Clinical Research
Los Angeles, California, United States
Orange Coast Medical Center
Newport Beach, California, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States
Johns Hopkins University, Center for Viral Hepatitis
Baltimore, Maryland, United States
• Adverse events • Laboratory evaluations • Human anti-chimeric antibody • Pharmacokinetic analysis
Blood levels of HCV RNA and HIV RNA (PCR)
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Saint Michael's Medical Center
Newark, New Jersey, United States
Southwest Infectious Disease Associates
Dallas, Texas, United States