Clinical trial NCT00307489 (phase 2, status: completed)
Conditions: chronic hepatitis b
ICD codes: B18.0, B18.1, B18.2, B18.8, B18.9
Drugs: tenofovir df, emtricitabine /tenofovir df
SMILES: [H][C@@](C)(CN1C=NC2=C(N)N=CN=C12)OCP(=O)(OCOC(=O)OC(C)C)OCOC(=O)OC(C)C, NC1=NC(=O)N(C=C1F)[C@@H]1CS[C@H](CO)O1
Eligibility criteria:

        Inclusion Criteria:

          -  18 through 69 years of age, inclusive

          -  Chronic HBV infection, defined as positive serum HBsAg for at least 6 months

          -  Active chronic HBV infection with all the following:

               1. Currently treated with adefovir dipivoxil 10 mg QD (for at least 24 weeks but not
                  more than 96 weeks)

               2. HBeAg positive or negative at screening

               3. Plasma HBV DNA >/= 1000 copies/mL at screening (irrespective of HBeAg status)

               4. Serum ALT less than 10 times the upper limit of normal (ULN)

               5. Calculated creatinine clearance of at least 70 mL/min using the Cockcroft-Gault
                  formula

               6. Hemoglobin at least 8 g/dL

               7. Neutrophils at least 1,000 /mm3

          -  Nucleoside naive except for lamivudine (>/= 12 weeks of therapy)

          -  Negative serum beta human chorionic gonadotropin

          -  Compliant with adefovir dipivoxil

          -  Willing and able to provide written informed consent

        Exclusion Criteria:

          -  Pregnant women, women who are breastfeeding or who believe they may wish to become
             pregnant during the course of the study

          -  Male or females of reproductive potential who are unwilling to use an effective method
             of contraceptive while enrolled in the study. For males, condoms should be used and
             for females, a barrier contraception method should be used

          -  Decompensated liver disease defined as conjugated bilirubin greater than 1.5 times
             ULN, prothrombin time (PT) greater than 1.5 times ULN, platelets less than 75,000/mm3,
             serum albumin less than 3.0 g/dL, or prior history of clinical hepatic decompensation
             (eg, ascites, jaundice, encephalopathy, variceal hemorrhage)

          -  Prior use of tenofovir DF or entecavir

          -  Received treatment with interferon or pegylated interferon within 6 months of the
             screening visit

          -  Evidence of hepatocellular carcinoma (HCC); for example, alpha-fetoprotein greater
             than 50 ng/mL or by any other standard of care measure.

          -  Co-infection with HCV (based on serology), human immunodeficiency virus (HIV), or
             hepatitis delta virus (HDV)

          -  Significant renal, cardiovascular, pulmonary, or neurological disease.

          -  Received solid organ or bone marrow transplantation.

          -  Is currently receiving therapy with immunomodulators (eg, corticosteroids, etc.),
             investigational agents, nephrotoxic agents, or agents capable of modifying renal
             excretion

          -  Has proximal tubulopathy

          -  Known hypersensitivity to the study drugs (tenofovir DF or emtricitabine/tenofovir
             DF), the metabolites (tenofovir or emtricitabine) or formulation excipients