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

Hiv Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00503347
• Other study ID #: PPHM 0603
• Status: Completed
• Phase: Phase 1
• First received: July 16, 2007
• Last updated: June 7, 2011
• Start date: July 2007
• Est. completion date: June 2011

Study information

• Verified date: June 2011
• Source: Peregrine Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C Virus
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Hiv Infections
• Immunologic Deficiency Syndromes

Intervention

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.

Locations

Country	Name	City	State
United States	AIDS Research Consortium of Atlanta	Atlanta	Georgia
United States	Johns Hopkins University, Center for Viral Hepatitis	Baltimore	Maryland
United States	Southwest Infectious Disease Associates	Dallas	Texas
United States	Impact Clinical Research	Los Angeles	California
United States	Saint Michael's Medical Center	Newark	New Jersey
United States	Orange Coast Medical Center	Newport Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
Peregrine Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• Adverse events • Laboratory evaluations • Human anti-chimeric antibody • Pharmacokinetic analysis		Unknown	Yes
Secondary	Blood levels of HCV RNA and HIV RNA (PCR)		Unknown	No

External Links

•   Click here for more information about bavituximab and this study: A safety and pharmacokinetic study of bavituximab in patients co-infected with chronic hepatitis C virus and human immunodeficiency virus.