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

Primary Purpose

Hepatitis B

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Entecavir
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis B

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 31, 2002
Last Updated
April 7, 2011
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00051038
Brief Title
Study of Adding Entecavir to Current Lamivudine Therapy in HIV and HBV Co-Infected Patients
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 Type
Interventional

2. Study Status

Record Verification Date
August 2007
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
October 2005 (Actual)
Study Completion Date
October 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Entecavir

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Local Institution
City
New Haven
State/Province
Connecticut
Country
United States
Facility Name
Local Institution
City
Altamonte Springs
State/Province
Florida
Country
United States
Facility Name
Local Institution
City
Lousiville
State/Province
Kentucky
Country
United States
Facility Name
Local Institution
City
Charlotte
State/Province
North Carolina
Country
United States
Facility Name
Local Institution
City
Pittsburgh
State/Province
Pennsylvania
Country
United States

12. IPD Sharing Statement

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

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