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

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

Tracking Information

• First Submitted Date: December 31, 2002
• First Posted Date: January 3, 2003
• Last Update Posted Date: April 14, 2011
• Study Start Date: September 2002
• Actual Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures: Not Provided
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2; Phase 3
• Study Design: Primary Purpose: Treatment
• Condition: Hepatitis B
• Intervention: Drug: Entecavir
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Enrollment: Not Provided
• Original Enrollment: Not Provided
• Actual Study Completion Date: October 2005
• Actual Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 16 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00051038
• Other Study ID Numbers: AI463-038
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: Bristol-Myers Squibb
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Bristol-Myers Squibb
• Verification Date: August 2007