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COMPLETEDPHASE1

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

NCT00503347•Peregrine Pharmaceuticals

View on ClinicalTrials.gov

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

Eligibility

Age

18 - No limit years

Sex

ALL

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
+10 more criteria

Locations (6)

Impact Clinical Research

Los Angeles, California, United States

Orange Coast Medical Center

Newport Beach, California, United States

AIDS Research Consortium of Atlanta

Atlanta, Georgia, United States

Johns Hopkins University, Center for Viral Hepatitis

Baltimore, Maryland, United States

Saint Michael's Medical Center

Newark, New Jersey, United States

Southwest Infectious Disease Associates

Dallas, Texas, United States

Key Dates

Start Date

July 1, 2007

Primary Completion Date

March 1, 2011

Completion Date

June 1, 2011

Last Updated

June 9, 2011

Enrollment

ESTIMATED participants

Conditions

Hepatitis C VirusHiv Infections

Interventions

bavituximab

DRUG

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RECRUITING

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 9, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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