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

Sponsor

Peregrine Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00503347

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Hepatitis C Virus Hiv Infections	Drug: bavituximab	Phase 1

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Jul 1, 2007

Actual Primary Completion Date :

Mar 1, 2011

Actual Study Completion Date :

Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

• Adverse events • Laboratory evaluations • Human anti-chimeric antibody • Pharmacokinetic analysis []

Secondary Outcome Measures

Blood levels of HCV RNA and HIV RNA (PCR) []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Impact Clinical Research	Los Angeles	California	United States	90036
2	Orange Coast Medical Center	Newport Beach	California	United States	92663
3	AIDS Research Consortium of Atlanta	Atlanta	Georgia	United States	30308
4	Johns Hopkins University, Center for Viral Hepatitis	Baltimore	Maryland	United States	21287
5	Saint Michael's Medical Center	Newark	New Jersey	United States	07102
6	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)