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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Hepatitis B

Treatments: Drug: Entecavir

Study type: Interventional

Funder types: Industry

Identifiers

NCT00051038

AI463-038

Details and patient eligibility

About

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.

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.