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

Primary Purpose

Hepatitis C Virus, Hiv Infections

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

bavituximab

About this trial

This is an interventional treatment trial for Hepatitis C Virus focused on measuring coinfection with chronic hepatitis C virus and HIV, Treatment Naive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Impact Clinical Research
Orange Coast Medical Center
AIDS Research Consortium of Atlanta
Johns Hopkins University, Center for Viral Hepatitis
Saint Michael's Medical Center
Southwest Infectious Disease Associates

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Arm Description

0.3 mg/kg

1 mg/kg

3 mg/kg

6 mg/kg

Outcomes

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)

Full Information

NCT ID

NCT00503347

First Posted

July 16, 2007

Last Updated

June 7, 2011

Sponsor

Peregrine Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00503347

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

June 2011

Overall Recruitment Status

Completed

Study Start Date

July 2007 (undefined)

Primary Completion Date

March 2011 (Actual)

Study Completion Date

June 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Peregrine Pharmaceuticals

4. Oversight

5. 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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis C Virus, Hiv Infections

Keywords

coinfection with chronic hepatitis C virus and HIV, Treatment Naive

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

0.3 mg/kg

Arm Title

Arm Type

Experimental

Arm Description

1 mg/kg

Arm Title

Arm Type

Experimental

Arm Description

3 mg/kg

Arm Title

Arm Type

Experimental

Arm Description

6 mg/kg

Intervention Type

Drug

Intervention Name(s)

bavituximab

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Blood levels of HCV RNA and HIV RNA (PCR)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials: