None listed
Conditions
Interventions
Entecavir 1 mg Type of group
Entecavir 1 mg is given for 24 weeks
Group name:placebo Type of group
placebo will be administered entecavir 1 mg and lamivudine 150 mg
Sponsors
BRISTOL MYERS SQUIBB PERU S.A.,
Eligibility
Inclusion criteria
Inclusion 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.
Exclusion criteria
Exclusion criteria: not contemplated
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:not contemplated Measure:not contemplated Timepoints:not contemplated | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:not contemplated Measure:not contemplated Timepoints:not contemplated | — |
Countries
Peru, United States
Outcome results
None listed