Bavituximab Repeat-Dose Trial in Patients Co-Infected With Chronic Hepatitis C Virus and Human Immunodeficiency Virus
This study has been completed.
Sponsor:
Peregrine Pharmaceuticals
Information provided by:
Peregrine Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00503347
First received: July 16, 2007
Last updated: June 7, 2011
Last verified: June 2011
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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 | Intervention | Phase |
---|---|---|
Hepatitis C Virus Hiv Infections |
Drug: bavituximab |
Phase 1 |
Study Type: | Interventional |
Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
Drug Information available for:
Hepatitis A Vaccines
U.S. FDA Resources
Further study details as provided by Peregrine Pharmaceuticals:
Primary Outcome Measures:
- • Adverse events • Laboratory evaluations • Human anti-chimeric antibody • Pharmacokinetic analysis [ Time Frame: Unknown ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Blood levels of HCV RNA and HIV RNA (PCR) [ Time Frame: Unknown ] [ Designated as safety issue: No ]
Estimated Enrollment: | 24 |
Study Start Date: | July 2007 |
Study Completion Date: | June 2011 |
Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
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.
|
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
![](https://webarchive.library.unt.edu/web/20130305100048im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00503347
Locations
United States, California | |
Impact Clinical Research | |
Los Angeles, California, United States, 90036 | |
Orange Coast Medical Center | |
Newport Beach, California, United States, 92663 | |
United States, Georgia | |
AIDS Research Consortium of Atlanta | |
Atlanta, Georgia, United States, 30308 | |
United States, Maryland | |
Johns Hopkins University, Center for Viral Hepatitis | |
Baltimore, Maryland, United States, 21287 | |
United States, New Jersey | |
Saint Michael's Medical Center | |
Newark, New Jersey, United States, 07102 | |
United States, Texas | |
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) |
![](https://webarchive.library.unt.edu/web/20130305100048im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Additional Information:
No publications provided
Responsible Party: | Jill Capps / Clinical Program Manager, Peregrine Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00503347 History of Changes |
Other Study ID Numbers: | PPHM 0603 |
Study First Received: | July 16, 2007 |
Last Updated: | June 7, 2011 |
Health Authority: | United States: Food and Drug Administration |
Keywords provided by Peregrine Pharmaceuticals:
coinfection with chronic hepatitis C virus and HIV Treatment Naive |
Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome HIV Infections Hepatitis Hepatitis A Hepatitis, Chronic Hepatitis C Immunologic Deficiency Syndromes Virus Diseases Hepatitis C, Chronic Lentivirus Infections Retroviridae Infections RNA Virus Infections Sexually Transmitted Diseases, Viral |
Sexually Transmitted Diseases Slow Virus Diseases Immune System Diseases Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Enterovirus Infections Picornaviridae Infections Flaviviridae Infections Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on March 03, 2013