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Study of Adding Entecavir to Current Lamivudine Therapy in HIV and HBV Co-Infected Patients

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ClinicalTrials.gov Identifier: NCT00051038
Recruitment Status : Completed
First Posted : January 3, 2003
Last Update Posted : April 14, 2011
Sponsor:
Information provided by:
Bristol-Myers Squibb

Study Description
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Brief Summary:
The purpose of this clinical research study is to assess the safety and effectiveness of entecavir, when being added to lamivudine, in the treatment of adults with chronic hepatitis B infection who are co-infected with HIV.

Condition or disease Intervention/treatment Phase
Hepatitis B Drug: Entecavir Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Phase II Study of the Safety and Efficacy of Adding Entecavir to Current Lamivudine Therapy in HIV and HBV Co-Infected Patients Who Have Hepatitis B Viremia While Being Treated With Lamivudine
Study Start Date : September 2002
Actual Primary Completion Date : October 2005
Actual Study Completion Date : October 2005

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • Documented history of co-infection with HIV and HBV
  • Stable Anti Retroviral Therapy regimen containing lamivudine 150 mg BID for at least 24 weeks prior to enrollment;
  • Documented HBV viremia on screening and at least at 4 weeks prior to screening
  • HBe Ag-positive or HBe Ag-negative / anti-HBe-positive
  • HIV viral load below 400 copies/mL by the Roche Amplicor(TM) 1.5 HIV PCR assay at screening and equally low at least 12 weeks prior to screening
  • Absence of Co-Infection with hepatitis C virus (HCV) or hepatitis D virus (HDV)
  • Absence of other forms of liver disease e.g., alcoholic, autoimmune, biliary disease
  • Less that 1/2 weeks of prior therapy with nucleoside/nucleotide analogue (excluding lamivudine) with activity against HBV (including e.g. famciclovir, tenofovir, ganciclovir, adefovir). No receipt of any of these therapies within 24 weeks prior to randomization into this study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00051038


Locations
United States, Connecticut
Local Institution
New Haven, Connecticut, United States
United States, Florida
Local Institution
Altamonte Springs, Florida, United States
United States, Kentucky
Local Institution
Lousiville, Kentucky, United States
United States, North Carolina
Local Institution
Charlotte, North Carolina, United States
United States, Pennsylvania
Local Institution
Pittsburgh, Pennsylvania, United States
Sponsors and Collaborators
Bristol-Myers Squibb
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

ClinicalTrials.gov Identifier: NCT00051038     History of Changes
Other Study ID Numbers: AI463-038
First Posted: January 3, 2003    Key Record Dates
Last Update Posted: April 14, 2011
Last Verified: August 2007

Additional relevant MeSH terms:
Hepatitis
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Lamivudine
 Entecavir
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents