Bavituximab Repeat-Dose Trial in Patients Co-Infected With Chronic Hepatitis C Virus and Human Immunodeficiency Virus

This study has been completed.
Sponsor:
Information provided by:
Peregrine Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00503347
First received: July 16, 2007
Last updated: June 7, 2011
Last verified: June 2011
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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
Study Completion Date: June 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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.
Experimental: 2
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.
Experimental: 3
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.
Experimental: 4
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. Corticosteroids administered as pre-treatment, or to treat an adverse event, are allowed.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00503347

Locations
United States, California
Impact Clinical Research
Los Angeles, California, United States, 90036
Orange Coast Medical Center
Newport Beach, California, United States, 92663
United States, Georgia
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States, 30308
United States, Maryland
Johns Hopkins University, Center for Viral Hepatitis
Baltimore, Maryland, United States, 21287
United States, New Jersey
Saint Michael's Medical Center
Newark, New Jersey, United States, 07102
United States, Texas
Southwest Infectious Disease Associates
Dallas, Texas, United States, 75204
Sponsors and Collaborators
Peregrine Pharmaceuticals
Investigators
Principal Investigator: Jihad Slim, 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
Principal Investigator: Lydie Hazan, MD Impact Clinical Trials
Principal Investigator: Melaine Thompson, MD AIDS Research Consortium of Atlanta (ARCA)
  More Information

Additional Information:
No publications provided

Responsible Party: Jill Capps / Clinical Program Manager, Peregrine Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00503347     History of Changes
Other Study ID Numbers: PPHM 0603
Study First Received: July 16, 2007
Last Updated: June 7, 2011
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on September 16, 2014