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Bavituximab Repeat-Dose Trial in Patients Co-Infected With Chronic Hepatitis C Virus and Human Immunodeficiency Virus
This study is currently recruiting participants.
Verified by Peregrine Pharmaceuticals, June 2009
First Received: July 16, 2007   Last Updated: June 2, 2009   History of Changes
Sponsored by: Peregrine Pharmaceuticals
Information provided by: Peregrine Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00503347
  Purpose

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.


Condition Intervention Phase
Hepatitis C Virus
HIV Infections
Drug: bavituximab
Phase I

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
Official Title: A Phase Ib Open-Label, Escalating Repeat-Dose Trial of Bavituximab (Chimeric Anti-Phosphatidylserine Monoclonal Antibody) in Patients Co-Infected With Chronic Hepatitis C Virus and Human Immunodeficiency Virus

Resource links provided by NLM:


Further study details as provided by Peregrine Pharmaceuticals:

Primary Outcome Measures:
  • • Adverse events • Laboratory evaluations • Human anti-chimeric antibody • Pharmacokinetic analysis [ Time Frame: Unknown ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Blood levels of HCV RNA and HIV RNA (PCR) [ Time Frame: Unknown ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: July 2007
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
0.3 mg/kg
Drug: bavituximab

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.

2: Experimental
1 mg/kg
Drug: bavituximab

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.

3: Experimental
3 mg/kg
Drug: bavituximab

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.

4: Experimental
6 mg/kg
Drug: bavituximab

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.


Detailed Description:

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent has been obtained
  • Adults 18 years of age or older
  • HIV infection documented by detectable HIV RNA PCR
  • Absolute CD4+ > 300 cells/mm3
  • Chronic hepatitis C infection based on history and detectable serum HCV RNA
  • Serum alanine aminotransferase (ALT) above normal limits and/or historical biopsy consistent with hepatitis C
  • Complete blood counts within normal limits
  • Normal renal function (serum creatinine within normal limits)
  • PT/INR and aPTT within normal limits
  • All patients of reproductive potential must agree to use an approved form of barrier contraception or agree not to become pregnant while taking study medications and for 30 days after study completion. Female patients must have a negative serum pregnancy test at prestudy (not applicable to patients with bilateral oophorectomy and/or hysterectomy or to those patients who are postmenopausal)

Exclusion Criteria:

  • HCV or HIV antiviral therapy within 4 weeks of Day 0
  • Prior exposure to any chimeric antibody
  • Any other cause of liver disease other than chronic hepatitis C, such as autoimmune or alcoholic liver disease.
  • Decompensated clinical liver disease, including a history of prolonged clotting times, hypoalbuminemia, encephalopathy, treatment for elevated ammonia levels, or ascites
  • Any evidence of clinically significant bleeding defined as gross hematuria, hemoptysis, or gastrointestinal bleeding
  • Known history of bleeding diathesis or coagulopathy (e.g., von Willebrand Disease or Hemophilia)
  • Any history of thromboembolic events [e.g., deep vein thrombosis (DVT) or pulmonary thromboembolism (PE)].

A history of including central venous catheter-related thrombosis is acceptable if there is documentation of resolution at least 12 months prior to enrollment.

  • Concurrent therapy with oral or parenteral anticoagulants
  • Concurrent hormone therapy (i.e., estrogen contraceptives, hormone replacement, anti-estrogen)
  • Investigational therapy within 4 weeks of Day 0
  • Major surgery within 4 weeks of Day 0
  • Pregnant or nursing women
  • Uncontrolled intercurrent disease (e.g., diabetes, hypertension, thyroid disease)
  • Any history of angina pectoris, coronary artery disease or cerebrovascular accident, or transient ischemic attack
  • A history of any condition requiring anti-platelet therapy with the exception of general cardiovascular prophylaxis with aspirin
  • A history of any condition requiring treatment (past or current) with coumarin-type agents
  • Cardiac arrhythmia requiring medical therapy
  • Serious non-healing wound (including wound healing by secondary intention, ulcer, or bone fracture)
  • Requirement for chronic daily treatment with NSAIDs, antiplatelet drugs (e.g., phosphodiesterase inhibitors, adenosine diphosphate receptor antagonists), or steroids
  • Cancer, autoimmune disease or any disease or concurrent therapy known to cause significant alteration in immunologic function
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00503347

Contacts
Contact: Dianne Uphoff, RN, CCRA 714-508-6031 duphoff@peregrineinc.com
Contact: Jennifer Lai, MBA, CCRA 714-508-6097 jlai@peregrineinc.com

Locations
United States, California
Orange Coast Medical Center Recruiting
Newport Beach, California, United States, 92663
Contact: Rosie Magallon     949-646-1111        
Principal Investigator: Jorge Rodriguez, MD            
United States, Maryland
Johns Hopkins University, Center for Viral Hepatitis Recruiting
Baltimore, Maryland, United States, 21287
Contact: Heather Thomas, RN, BSN     410-614-0452        
Principal Investigator: Mark S. Sulkowski, MD            
United States, New Jersey
Saint Michael's Medical Center Recruiting
Newark, New Jersey, United States, 07102
Contact: James Fallon     973-877-2663        
Principal Investigator: Stephen M Smith, MD            
United States, Texas
Southwest Infectious Disease Associates Recruiting
Dallas, Texas, United States, 75204
Contact: Denise Hayes     214-828-4702 ext 102        
Principal Investigator: Nicholaos C. Bellos, MD            
Sponsors and Collaborators
Peregrine Pharmaceuticals
Investigators
Principal Investigator: Stephen M Smith, MD Saint Michael's Medical Center
Principal Investigator: Mark S. Sulkowski, MD Johns Hopkins University, Center for Viral Hepatitis
Principal Investigator: Jorge Rodriguez, MD Orange Coast Medical Center
Principal Investigator: Nicholaos C. Bellos, MD Southwest Infectious Disease Associates
  More Information

Additional Information:
No publications provided

Responsible Party: Peregrine Pharmaceuticals ( Dianne Uphoff/Senior Clinical Project Manager )
Study ID Numbers: PPHM 0603
Study First Received: July 16, 2007
Last Updated: June 2, 2009
ClinicalTrials.gov Identifier: NCT00503347     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Peregrine Pharmaceuticals:
coinfection with chronic hepatitis C virus and HIV
Treatment Naive

Study placed in the following topic categories:
Sexually Transmitted Diseases, Viral
Liver Diseases
Hepatitis, Chronic
Acquired Immunodeficiency Syndrome
Hepatitis, Viral, Human
Immunologic Deficiency Syndromes
Antibodies, Monoclonal
Hepatitis
Virus Diseases
Antibodies
Digestive System Diseases
HIV Infections
Sexually Transmitted Diseases
Hepatitis C
Hepatitis C, Chronic
Retroviridae Infections
Immunoglobulins

Additional relevant MeSH terms:
Liver Diseases
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Flaviviridae Infections
Immune System Diseases
Hepatitis, Chronic
Acquired Immunodeficiency Syndrome
Hepatitis, Viral, Human
Infection
Immunologic Deficiency Syndromes
Hepatitis
Virus Diseases
Digestive System Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Hepatitis C
Hepatitis C, Chronic
Retroviridae Infections

ClinicalTrials.gov processed this record on September 11, 2009