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

NCT00503347 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2011-06-09

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Peregrine Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Jihad Slim, MD · Saint Michael's Medical Center

  • Mark S. Sulkowski, MD · Johns Hopkins University, Center for Viral Hepatitis

  • Jorge Rodriguez, MD · Orange Coast Medical Center

  • Nicholaos C. Bellos, MD · Southwest Infectious Disease Associates

  • Lydie Hazan, MD · Impact Clinical Trials

  • Melaine Thompson, MD · AIDS Research Consortium of Atlanta (ARCA)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2011-03-31
Completion
2011-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00503347 on ClinicalTrials.gov