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

NCT00503347 | Completed Phase 1

• 1 other identifier: PPHM 0603
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 6

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.

Conditions

Hepatitis C Virus; Hiv Infections

Keywords

coinfection with chronic hepatitis C virus and HIV; Treatment Naive

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

• Blood levels of HCV RNA and HIV RNA (PCR)

Study Arms (4)

1

EXPERIMENTAL

0.3 mg/kg

Drug: bavituximab

2

EXPERIMENTAL

1 mg/kg

Drug: bavituximab

3

EXPERIMENTAL

3 mg/kg

Drug: bavituximab

4

EXPERIMENTAL

6 mg/kg

Drug: bavituximab

Interventions

bavituximab DRUG

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.

1; 2; 3; 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Peregrine Pharmaceuticals: lead

Study Sites (6)

Impact Clinical Research

Los Angeles, California, 90036, United States

Location

Orange Coast Medical Center

Newport Beach, California, 92663, United States

Location

AIDS Research Consortium of Atlanta

Atlanta, Georgia, 30308, United States

Location

Johns Hopkins University, Center for Viral Hepatitis

Baltimore, Maryland, 21287, United States

Location

Saint Michael's Medical Center

Newark, New Jersey, 07102, United States

Location

Southwest Infectious Disease Associates

Dallas, Texas, 75204, United States

Location

MeSH Terms

Conditions

Hepatitis C; HIV Infections

Interventions

bavituximab

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• 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)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 16, 2007
• First Posted: July 18, 2007
• Study Start: July 1, 2007
• Primary Completion: March 1, 2011
• Study Completion: June 1, 2011
• Last Updated: June 9, 2011

Record last verified: 2011-06

Locations

US (6)