Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00051038
First received: December 31, 2002
Last updated: April 7, 2011
Last verified: August 2007
  Purpose

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 Intervention Phase
Hepatitis B
Drug: Entecavir
Phase 2
Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Study Start Date: September 2002
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00051038     History of Changes
Other Study ID Numbers: AI463-038
Study First Received: December 31, 2002
Last Updated: April 7, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 19, 2014