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

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

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)

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
  • 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.
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Please refer to this study by its identifier: NCT00051038

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 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:
Anti-Infective Agents
Antiviral Agents
Pharmacologic Actions
Therapeutic Uses processed this record on March 25, 2015