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

July 16, 2007
June 7, 2011
July 2007
March 2011   (final data collection date for primary outcome measure)
• Adverse events • Laboratory evaluations • Human anti-chimeric antibody • Pharmacokinetic analysis [ Time Frame: Unknown ] [ Designated as safety issue: Yes ]
• Adverse events • Laboratory evaluations • Human anti-chimeric antibody • Pharmacokinetic analysis
Complete list of historical versions of study NCT00503347 on ClinicalTrials.gov Archive Site
Blood levels of HCV RNA and HIV RNA (PCR) [ Time Frame: Unknown ] [ Designated as safety issue: No ]
Blood levels of HCV RNA and HIV RNA (PCR)
Not Provided
Not Provided
 
Bavituximab Repeat-Dose Trial in Patients Co-Infected With Chronic Hepatitis C Virus and Human Immunodeficiency Virus
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

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
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hepatitis C Virus
  • Hiv Infections
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: 1
    0.3 mg/kg
    Intervention: Drug: bavituximab
  • Experimental: 2
    1 mg/kg
    Intervention: Drug: bavituximab
  • Experimental: 3
    3 mg/kg
    Intervention: Drug: bavituximab
  • Experimental: 4
    6 mg/kg
    Intervention: Drug: bavituximab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
June 2011
March 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00503347
PPHM 0603
Not Provided
Jill Capps / Clinical Program Manager, Peregrine Pharmaceuticals
Peregrine Pharmaceuticals
Not Provided
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)
Peregrine Pharmaceuticals
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP