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

December 31, 2002
April 7, 2011
September 2002
October 2005   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00051038 on ClinicalTrials.gov Archive Site
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Study of Adding Entecavir to Current Lamivudine Therapy in HIV and HBV Co-Infected Patients
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

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.

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Interventional
Phase 2
Phase 3
Primary Purpose: Treatment
Hepatitis B
Drug: Entecavir
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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October 2005
October 2005   (final data collection date for primary outcome measure)
  • 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.
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00051038
AI463-038
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Bristol-Myers Squibb
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Bristol-Myers Squibb
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP